Trial Outcomes & Findings for Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma (NCT NCT03463265)
NCT ID: NCT03463265
Last Updated: 2023-11-07
Results Overview
Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology \[RANO\]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Through study completion (up to 48 months)
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma
nab-sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin): 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. Two dose reduction levels allowed for toxicities: 75 mg/m2 and 60 mg/m2
|
Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
ABI-009: IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Bevacizumab: IV infusion (90 minutes 1st dose, 60 minutes 2nd dose, and 30 minutes afterward assuming tolerability) at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle. Bevacizumab administered approximately 10 minutes after the end of the ABI-009.
|
Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Temozolomide: PO at 50 mg/m2 daily.
|
Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Lomustine (CCNU): PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks)
|
ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days
1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed for toxicities: 45, 30, and 20 mg/m2.
MRZ: 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ administered approximately 10 minutes after the end of the ABI-009 infusion.
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
Concomitant Treatment: starting 1 week after the completion of Induction Treatment and lasting for 6 weeks (2 cycles).
ABI-009: IV at 60 mg/m2 as a 30-minute IV infusion on Days 8 and 15 of every 21-day cycle. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Temozolomide: 75 mg/m2 PO daily for 6 weeks. Focal RT: daily at 30 x 200 cGy, 5 days/week for a total dose of 60 Gy (or equivalent regimens as per RTOG guidelines)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
9
|
4
|
10
|
26
|
|
Overall Study
COMPLETED
|
7
|
6
|
9
|
4
|
10
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
Baseline characteristics by cohort
| Measure |
Arm A: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=7 Participants
nab-sirolimus (ABI-009, nab-rapamycin, albumin-bound rapamycin): 100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. Two dose reduction levels allowed for toxicities: 75 mg/m2 and 60 mg/m2
|
Arm A: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=6 Participants
ABI-009: IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Bevacizumab: IV infusion (90 minutes 1st dose, 60 minutes 2nd dose, and 30 minutes afterward assuming tolerability) at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle. Bevacizumab administered approximately 10 minutes after the end of the ABI-009.
|
Arm A: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=9 Participants
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Temozolomide: PO at 50 mg/m2 daily.
|
Arm A: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Lomustine (CCNU): PO at 90 mg/m2 on Day 1 of each odd 21-day cycle (ie, every 6 weeks)
|
ArmA: Nab-sirolimus + Marizomib (MRZ) in Patients With Recurrent High Grade Glioma
n=10 Participants
ABI-009: 60 mg/m 2 as a 30-minute IV infusion on Days
1, 8, and 15 of every 28-day cycle. If ABI-009 is well tolerated at 60 mg/m2 in the first 3 patients in the cohort, the dose may be increased to 75 mg/m2. Three dose reduction levels allowed for toxicities: 45, 30, and 20 mg/m2.
MRZ: 0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle. MRZ administered approximately 10 minutes after the end of the ABI-009 infusion.
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
Concomitant Treatment: starting 1 week after the completion of Induction Treatment and lasting for 6 weeks (2 cycles).
ABI-009: IV at 60 mg/m2 as a 30-minute IV infusion on Days 8 and 15 of every 21-day cycle. Three dose reduction levels allowed: 45, 30, and 20 mg/m2.
Temozolomide: 75 mg/m2 PO daily for 6 weeks. Focal RT: daily at 30 x 200 cGy, 5 days/week for a total dose of 60 Gy (or equivalent regimens as per RTOG guidelines)
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Age, Continuous
|
60 years
n=93 Participants
|
53.5 years
n=4 Participants
|
60 years
n=27 Participants
|
53 years
n=483 Participants
|
52.5 years
n=36 Participants
|
64 years
n=10 Participants
|
60 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
58 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
4 participants
n=483 Participants
|
10 participants
n=36 Participants
|
26 participants
n=10 Participants
|
62 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Through study completion (up to 48 months)Population: Efficacy Analysis Set
Objective overall response rate (ORR, according to Response Assessment in Neuro-Oncology \[RANO\]) by investigator-assessed radiologic review and defined as the proportion of patients who achieved a confirmed partial response (PR) or confirmed complete response (CR) per RANO 2010 criteria. PR is defined as greater than or equal to 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.
Outcome measures
| Measure |
Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=8 Participants
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
ORR
|
0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
11.5 percentage of patients
Interval 2.4 to 30.2
|
SECONDARY outcome
Timeframe: Through study completion (up to 48 months)Population: Efficacy Analysis Set
Progression-free Survival defined as number of months from the date of the first dose of study drug to the first observation of a disease progression or death due to any cause. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids.
Outcome measures
| Measure |
Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=8 Participants
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
Median PFS
|
1.7 months
Interval 1.3 to
Upper limit was not reached due to insufficient number of participants with events
|
11.3 months
Interval 5.2 to
Upper limit was not reached due to insufficient number of participants with events
|
3.1 months
Interval 1.7 to 9.2
|
3.8 months
Interval 1.4 to
Upper limit was not reached due to insufficient number of participants with events
|
1.7 months
Interval 0.9 to 3.5
|
7.5 months
Interval 6.2 to 14.4
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Efficacy Analysis Set
Progression-free survival rate at 6 months and 12 months was calculated as the proportion of patients who were progression-free and alive at 6 and 12 months, respectively. Progression is assessed according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria based on MRI imaging, and includes ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids.
Outcome measures
| Measure |
Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=8 Participants
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
PFS Rate at 6 Months and 12 Months
PFS at 6 months
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
75.0 percentage of patients
Interval 12.8 to 96.1
|
37.5 percentage of patients
Interval 8.7 to 67.4
|
25.0 percentage of patients
Interval 0.9 to 66.5
|
10.0 percentage of patients
Interval 0.6 to 35.8
|
76.9 percentage of patients
Interval 55.7 to 88.9
|
|
PFS Rate at 6 Months and 12 Months
PFS at 12 months
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
50.0 percentage of patients
Interval 5.8 to 84.5
|
12.5 percentage of patients
Interval 0.7 to 42.3
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
36.4 percentage of patients
Interval 18.5 to 54.7
|
SECONDARY outcome
Timeframe: Through study completion (up to 48 months)Population: Efficacy Analysis Set
Median Overall Survival
Outcome measures
| Measure |
Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=8 Participants
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
OS
|
7.2 months
Interval 2.7 to
Upper limit was not reached due to insufficient number of participants with events
|
13.8 months
Interval 5.2 to
Upper limit was not reached due to insufficient number of participants with events
|
6.8 months
Interval 1.7 to 13.1
|
7.5 months
Interval 5.4 to
Upper limit was not reached due to insufficient number of participants with events
|
6.7 months
Interval 1.7 to 9.2
|
13.3 months
Interval 7.9 to 23.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Efficacy Analysis Set
Overall Survival rate at 12 months
Outcome measures
| Measure |
Arm A, Cohort 1: Nab-sirolimus in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=8 Participants
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 Participants
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 Participants
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
OS at 12 Months
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
66.7 percentage of patients
Interval 19.5 to 90.4
|
25.0 percentage of patients
Interval 3.7 to 55.8
|
25.0 percentage of patients
Interval 0.9 to 66.5
|
0.0 percentage of patients
The 95% CI could not be calculated as there were no patients with an event.
|
53.8 percentage of patients
Interval 33.3 to 70.6
|
Adverse Events
Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma
Serious events: 0 serious events
Other events: 7 other events
Deaths: 7 deaths
Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
Serious events: 0 serious events
Other events: 10 other events
Deaths: 10 deaths
Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
Serious events: 1 serious events
Other events: 26 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma
n=7 participants at risk
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=9 participants at risk
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 participants at risk
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Myelosuppression (thrombocytopenia)
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Myelossupression (neutropenia)
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
Other adverse events
| Measure |
Arm A, Cohort 1: Nab-Sirolimus in Patients With Recurrent High Grade Glioma
n=7 participants at risk
nab-Sirolimus single agent (100 mg/m2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle)
|
Arm A, Cohort 2: Nab-Sirolimus + Temozolomide in Patients With Recurrent High Grade Glioma
n=6 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Temozolomide (PO at 50 mg/m2 daily)
|
Arm A, Cohort 3: Nab-Sirolimus + Bevacizumab in Patients With Recurrent High Grade Glioma
n=9 participants at risk
nab-Sirolimus (IV 60 mg/m 2 as a 30-minute infusion on Days 1, 8, and 15 of every 28-day cycle) plus Bevacizumab (IV at a fixed dose of 5 mg/kg on Days 1 and 15 of every 28-day cycle)
|
Arm A, Cohort 4: Nab-Sirolimus + Lomustine in Patients With Recurrent High Grade Glioma
n=4 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1 and 8 of every 21-day cycle) plus Lomustine (CCNU, PO at 90 mg/m2 on Day 1 of each odd 21-day cycle, ie, every 6 weeks)
|
Arm A, Cohort 5: Nab-Sirolimus + Marizomib in Patients With Recurrent High Grade Glioma
n=10 participants at risk
nab-Sirolimus (60 mg/m 2 as a 30-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle) plus Marizomib (0.8 mg/m 2 as a 10-minute IV infusion on Days 1, 8, and 15 of every 28-day cycle)
|
Arm B: Nab-Sirolimus + Temozolomide + Radiotherapy in Patients With Newly Diagnosed Glioblastoma
n=26 participants at risk
4-week Induction Treatment with nab-sirolimus followed by Concomitant Treatment of nab-sirolimus + temozolomide + RT for 2 cycles, followed by adjuvant treatment of nab-sirolimus + temozolomide for 6 cycles
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mucositis
|
57.1%
4/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
83.3%
5/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
22.2%
2/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
50.0%
2/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
53.8%
14/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.1%
1/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.5%
3/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
40.0%
4/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Myelosuppression (thrombocytopenia)
|
28.6%
2/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
50.0%
3/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
55.6%
5/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
75.0%
3/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
70.0%
7/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
53.8%
14/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.5%
3/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Myelosuppression (anemia)
|
14.3%
1/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.9%
3/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
83.3%
5/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
3/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
75.0%
3/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
30.0%
3/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
46.2%
12/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
14.3%
1/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
22.2%
2/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
22.2%
2/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
19.2%
5/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
23.1%
6/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Blood and lymphatic system disorders
Myelossupression (neutropenia)
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.5%
3/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.5%
3/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.1%
1/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
3/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
50.0%
2/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
34.6%
9/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
3/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
23.1%
6/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
20.0%
2/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
3.8%
1/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Investigations
ALT
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
33.3%
2/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
22.2%
2/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
15.4%
4/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Investigations
AST
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
22.2%
2/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
15.4%
4/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
16.7%
1/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
10.0%
1/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.5%
3/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Infections and infestations
Infection
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
11.1%
1/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
15.4%
4/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/6 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/9 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
25.0%
1/4 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
0.00%
0/10 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
7.7%
2/26 • Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs, from the time the patient signed informed consent until 28 days after the last dose of nab-sirolimus, for up to 48 months (study duration).
All patients were evaluated for safety analysis if they received at least one dose of nab-sirolimus. Treatment with nab-sirolimus continued until disease progression or unacceptable AEs. Safety and tolerability was monitored during treatment (from signing of informed consent till 28 days after last dose), through reporting of AEs, serious AEs, laboratory abnormalities, and incidence of dose modifications, dose delay/dose not given, and/or premature discontinuation of nab-sirolimus due to an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place