Trial Outcomes & Findings for LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma (NCT NCT00859222)
NCT ID: NCT00859222
Last Updated: 2017-03-14
Results Overview
The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.
COMPLETED
PHASE1/PHASE2
51 participants
Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.
2017-03-14
Participant Flow
Participants in the Phase I study enrolled from March 2009-January 2011 and the Phase II study from June 2011-May 2013.
Participant milestones
| Measure |
Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
24
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
24
|
15
|
Reasons for withdrawal
| Measure |
Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
6
|
24
|
15
|
|
Overall Study
DLT
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma
Baseline characteristics by cohort
| Measure |
All Phase I Participants
n=12 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
n=24 Participants
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
n=15 Participants
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Histology
anaplastic oligoastrocytoma (AOA)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
53 years
n=7 Participants
|
48 years
n=5 Participants
|
50 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
0 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Number of Prior Relapses
1
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
7 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Number of Prior Relapses
2
|
0 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Number of Prior Relapses
3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Number of Prior Relapses
4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Histology
glioblastoma (GBM)
|
10 participants
n=5 Participants
|
24 participants
n=7 Participants
|
0 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Histology
anaplastic astrocytoma (AA)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Histology
anaplastic oligodendroglioma (AO)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.Population: All PI participants who received at least one dose of the study drug were evaluable for MTD.
The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.
Outcome measures
| Measure |
All Phase I Participants
n=12 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
LBH589 Maximum Tolerated Dose (MTD) [Phase I]
|
30 mg/day orally, 3x per wk, every other wk
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.Population: All PI participants who received at least one dose of the study drug were evaluable for DLT.
A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC\<0.5 x10\^9/L; a QT interval corrected for heart rate (QTc) of 500-515 msec that did not stabilize to \<480 msec after one week; a second occurrence of QTc 500-515 msec; any QTc \>515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.
Outcome measures
| Measure |
All Phase I Participants
n=3 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=3 Participants
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
n=6 Participants
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) [Phase I]
|
1 participants with DLT
|
0 participants with DLT
|
0 participants with DLT
|
—
|
—
|
PRIMARY outcome
Timeframe: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.Population: All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.
PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).
Outcome measures
| Measure |
All Phase I Participants
n=24 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=15 Participants
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
6-Month Progression-Free Survival (PFS6) [Phase II]
|
0.304 proportion of participants
Interval 0.124 to 0.507
|
0.467 proportion of participants
Interval 0.21 to 0.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.Population: All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.
Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.
Outcome measures
| Measure |
All Phase I Participants
n=3 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=3 Participants
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
n=6 Participants
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
n=24 Participants
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
n=15 Participants
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Best Radiographic Response
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Radiographic Response
Partial Response
|
0 participants
|
1 participants
|
2 participants
|
7 participants
|
4 participants
|
|
Best Radiographic Response
Stable Disease
|
2 participants
|
2 participants
|
3 participants
|
14 participants
|
9 participants
|
|
Best Radiographic Response
Progressive Disease
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.Population: All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.
PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.
Outcome measures
| Measure |
All Phase I Participants
n=24 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=15 Participants
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) [Phase II]
|
5 months
Interval 3.0 to 9.0
|
7 months
Interval 2.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.Population: All participants who received at least one dose of the study drug were followed for OS.
OS is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
All Phase I Participants
n=24 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=12 Participants
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival [Phase II]
|
9 months
Interval 6.0 to 19.0
|
17 months
Interval 5.0 to 27.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.Population: All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.
PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Outcome measures
| Measure |
All Phase I Participants
n=12 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) [Phase I]
|
4.3 months
Interval 1.1 to 9.5
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.Population: All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.
PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Outcome measures
| Measure |
All Phase I Participants
n=12 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
6-Month Progression-Free Survival (PFS6) [Phase I]
|
0.25 proportion of participants
Interval 0.063 to 0.551
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.Population: All participants who received at least one dose of the study drug were followed for OS.
OS is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
All Phase I Participants
n=12 Participants
All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival (OS) [Phase I]
|
8.2 months
Interval 4.8 to 12.1
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
Serious adverse events
| Measure |
Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
n=3 participants at risk
Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=3 participants at risk
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
n=6 participants at risk
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
n=24 participants at risk
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
n=15 participants at risk
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Investigations
ADH secretion abnormality (eg SIADH)
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
ALT, SGPT
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
CNS, hemorrhage
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Esophagus, hemorrhage
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.0%
3/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
QTc interval
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
4/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
Other adverse events
| Measure |
Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week
n=3 participants at risk
Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week
n=3 participants at risk
Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week
n=6 participants at risk
Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week
n=24 participants at risk
Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week
n=15 participants at risk
Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Alkaline phosphatase
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
ALT, SGPT
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
50.0%
3/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
40.0%
6/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Amylase
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
4/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.0%
3/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Anus, hemorrhage
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
AST, SGOT
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
4/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
4/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
26.7%
4/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Cardiac disorders
Cardiac-ischemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
CNS, hemorrhage
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Constitutional, other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Creatinine
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
83.3%
5/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
58.3%
14/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
10/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Edema limb
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
2/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
4/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
58.3%
14/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
46.7%
7/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
GI-other
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.0%
3/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hemorrhage-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Endocrine disorders
Hyopthyroidism
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
50.0%
3/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
4/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
40.0%
6/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Endocrine disorders
Hyperthyroidism, thyrotoxicosis
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut, vagina
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Infections and infestations
Infection-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Leak, CSF
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
66.7%
2/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
4/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
40.0%
6/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Lipase
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Metabolic/Laboratory-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.8%
5/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
5/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
66.7%
2/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
66.7%
4/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
40.0%
6/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
4/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.0%
3/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
General disorders
Pain-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Platelets
|
66.7%
2/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
83.3%
5/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
29.2%
7/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
40.0%
6/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
QTc interval
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
4.2%
1/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Nervous system disorders
Taste disturbance
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
26.7%
4/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
6.7%
1/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
25.0%
6/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
13.3%
2/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
33.3%
2/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
12.5%
3/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
20.0%
3/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/3 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
16.7%
1/6 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
8.3%
2/24 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
0.00%
0/15 • Assessed each treatment cycle from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 2 (1-6) Phase I Cohort 1, 4.5 (2-6) Phase I Cohort 2, 6 (2-10) Phase I Cohort 3, 5 Phase II GBM and 7 Phase II AG.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grade 3 or higher per CTCAEv3. Other AEs were defined as events with LBH589 and/or bevacizumab treatment-attribution of at least possibly and grades 1 or 2 per CTCAEv3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place