Trial Outcomes & Findings for RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma (NCT NCT01189240)
NCT ID: NCT01189240
Last Updated: 2015-12-14
Results Overview
Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
28 days
Results posted on
2015-12-14
Participant Flow
Phase I trial started 8/2011 and enrollment closed 7/31/12. 13 total patients treated by RO4929097 (5, 10, 20mg/kg) in combo with bevacizumab. 1 treated pt ineligible for study. Analysis data for toxicity included 13 treated pts. Analytical dataset results other than toxicity included 12 eligible pts only. Pts enrolled from outpt medical clinics
A decision was made from the company, Roche, the owner and developer of RO4929097, that as of 7/31/12 there would be no further supply of RO4929097 and all clinical trials using this drug must stop accruing and treating patients. Hence our ABTC 1002 study was stopped during the phase 1 with 13 pt accrued and the Phase 2 was unable to begin.
Participant milestones
| Measure |
Phase I Dose Finding - Level 1 5mg
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
|
Overall Study
COMPLETED
|
4
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma
Baseline characteristics by cohort
| Measure |
Phase I Dose Finding
n=12 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
6 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
5 participants
n=5 Participants
|
|
Karnofsky Performance Status
70
|
0 participants
n=5 Participants
|
|
Karnofsky Performance Status
60
|
1 participants
n=5 Participants
|
|
Mini Mental State Examination (MMSE)
|
29 units on a scale
n=5 Participants
|
|
Prior Relapses
1 relapse
|
8 participants
n=5 Participants
|
|
Prior Relapses
2 relapes
|
3 participants
n=5 Participants
|
|
Prior Relapses
3 relapses
|
1 participants
n=5 Participants
|
|
Initial Procedure
biopsy
|
1 participants
n=5 Participants
|
|
Initial Procedure
Resection
|
11 participants
n=5 Participants
|
|
Initial Histological Diagnosis
Glioblastoma
|
10 participants
n=5 Participants
|
|
Initial Histological Diagnosis
Other
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: RO4929097 Days 1-3 weekly (doses 5,10, 20 mg) + Bev 10mg/kg IV q2 wks - cycle 28 days. 3+3 dose escalation method will be used. Target DLT is \> or equal to 33%
Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used
Outcome measures
| Measure |
Phase I Dose Finding
n=13 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I)
|
10 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days - 1 cyclePopulation: DLT Defintion, must be related to RO and/or Bev: ANC \</= 500/μL or second time ANC \<1,000/μL; PLTs \</= 25,000/μL or second time platelets \<50,000/μL; Febrile neutropenia;Thrombocytopenic bleeding (platelets \<50,000/μL and with clinically significant bleeding); Delay of treatment \> 14 days ;grade 3 or 4 non-hematological toxicity (some exceptions)
Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort. Pts must receive one dose of treatment to be evaluated for toxicity. Toxcity description associated with combination of RO4929097 and Bevacizumab
Outcome measures
| Measure |
Phase I Dose Finding
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
n=6 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
n=3 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Toxicity Description (Dose Limiting Toxicity-DLT) of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hrsPopulation: Day One only
all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1. For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected
Outcome measures
| Measure |
Phase I Dose Finding
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
n=6 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
n=3 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1
|
129 ng/mL
Standard Deviation 41
|
177 ng/mL
Standard Deviation 32
|
241 ng/mL
Standard Deviation 172
|
SECONDARY outcome
Timeframe: 24hrPopulation: Day 15 only. Level 2 10mg only had 5pts with evaluable PKs at day 15
all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.
Outcome measures
| Measure |
Phase I Dose Finding
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
n=5 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
n=3 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15
|
117 ng/mL
Standard Deviation 37
|
189 ng/mL
Standard Deviation 49
|
245 ng/mL
Standard Deviation 192
|
SECONDARY outcome
Timeframe: 24hrsPopulation: Day 1
all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.
Outcome measures
| Measure |
Phase I Dose Finding
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
n=6 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
n=3 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1
|
1,215 ng*h/mL
Standard Deviation 361
|
2,385 ng*h/mL
Standard Deviation 606
|
2,232 ng*h/mL
Standard Deviation 781
|
SECONDARY outcome
Timeframe: 24hrPopulation: Day 15. Only 4 pts samples were evaluable for AUC 24 at the10mg dose.
all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.
Outcome measures
| Measure |
Phase I Dose Finding
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 2 10mg
n=4 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase I Dose Finding Level 3 20mg
n=3 Participants
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15
|
1,212 ng*h/mL
Standard Deviation 355
|
2,351 ng*h/mL
Standard Deviation 1,071
|
2,555 ng*h/mL
Standard Deviation 1,363
|
Adverse Events
Phase I Dose Finding
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Finding
n=13 participants at risk
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Colonic perforation
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
Sigmoidectomy
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
Other adverse events
| Measure |
Phase I Dose Finding
n=13 participants at risk
Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
bevacizumab: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
30.8%
4/13 • Number of events 4 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Skin and subcutaneous tissue disorders
alopecia
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Blood and lymphatic system disorders
anemia
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
aspartate aminotransferase increase
|
23.1%
3/13 • Number of events 3 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
blood bilirubin increase
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
constipation
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
dyspepsia
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
dyspagia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Nervous system disorders
dysphasia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
General disorders
edema limbs
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Injury, poisoning and procedural complications
fall
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
General disorders
fatigue
|
53.8%
7/13 • Number of events 7 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Nervous system disorders
headaches
|
23.1%
3/13 • Number of events 3 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Vascular disorders
hematoma
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Vascular disorders
hypertension
|
38.5%
5/13 • Number of events 5 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Metabolism and nutrition disorders
hypokalemia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Reproductive system and breast disorders
irregular menstruation
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
mucositis oral
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
nausea
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
neutrophil count decrease
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
General disorders
non-cardiac chest pain
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
platelet count decrease
|
38.5%
5/13 • Number of events 5 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Cardiac disorders
vascular disorder
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Respiratory, thoracic and mediastinal disorders
voice alteration
|
15.4%
2/13 • Number of events 2 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Gastrointestinal disorders
vomiting
|
7.7%
1/13 • Number of events 1 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
|
Investigations
white blood cells decrease
|
38.5%
5/13 • Number of events 5 • First dose of drug, than weekly during cycle 1 and then once every 28 days until disease progression, approximately 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60