Trial Outcomes & Findings for Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM) (NCT NCT00555399)
NCT ID: NCT00555399
Last Updated: 2024-08-22
Results Overview
To determine the maximum tolerated dose (MTD) of vorinostat + isotretinoin (cRA), carboplatin (CBT) + cRA, and vorinostat + cRA + CBT combinations in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas. The units of measurement for the drug dose were either mg/day \[VOR and cRA\] or AUC \[CBT\]. In the outcome measure data table below we have provided the cohort number for each arm at which MTD was declared.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
62 months
Results posted on
2024-08-22
Participant Flow
55 participants were enrolled .
Participant milestones
| Measure |
Arm 1 Cohort 1
Cohort1= VOR 300mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-2
|
Arm 1 Cohort 2
Cohort 2=VOR 400 mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 3
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 1
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 2
CBT: Cohort2= AUC5 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 3
CBT: Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A Cohort 1
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 2
Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 3
Cohort3=Vor 300mg/day x14 days; CBT AUC5 Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 4
Cohort4=Vor 300 mg/day x14 days; CBT AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B Cohort 1
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
Arm 3B Cohort 2
Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
8
|
6
|
3
|
3
|
5
|
6
|
5
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
6
|
3
|
3
|
5
|
6
|
5
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 Cohort 1
Cohort1= VOR 300mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-2
|
Arm 1 Cohort 2
Cohort 2=VOR 400 mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 3
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 1
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 2
CBT: Cohort2= AUC5 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 3
CBT: Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A Cohort 1
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 2
Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 3
Cohort3=Vor 300mg/day x14 days; CBT AUC5 Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 4
Cohort4=Vor 300 mg/day x14 days; CBT AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B Cohort 1
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
Arm 3B Cohort 2
Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Patient decided not to proceed with treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)
Baseline characteristics by cohort
| Measure |
Arm 1 Cohort 1
n=3 Participants
Cohort1= VOR 300mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 2
n=3 Participants
Cohort 2=VOR 400 mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 3
n=8 Participants
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 1
n=6 Participants
CBT: Cohort1= AUC4 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 2
n=3 Participants
CBT: Cohort2= AUC5 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 3
n=3 Participants
CBT: Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A Cohort 1
n=5 Participants
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 2
n=6 Participants
Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 3
n=5 Participants
Cohort3=Vor 300mg/day x14 days; CBT AUC5 Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 4
n=3 Participants
Cohort4=Vor 300 mg/day x14 days; CBT AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B Cohort 1
n=3 Participants
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21
|
Arm 3B Cohort 2
n=7 Participants
Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
46 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
23 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
7 Participants
n=21 Participants
|
43 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
5 participants
n=115 Participants
|
6 participants
n=6 Participants
|
5 participants
n=6 Participants
|
3 participants
n=64 Participants
|
3 participants
n=17 Participants
|
7 participants
n=21 Participants
|
55 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 62 monthsPopulation: 52 out of 55 enrolled participants were evaluable. Two patients withdrew consents, and one patient chose not to proceed with treatment.
To determine the maximum tolerated dose (MTD) of vorinostat + isotretinoin (cRA), carboplatin (CBT) + cRA, and vorinostat + cRA + CBT combinations in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas. The units of measurement for the drug dose were either mg/day \[VOR and cRA\] or AUC \[CBT\]. In the outcome measure data table below we have provided the cohort number for each arm at which MTD was declared.
Outcome measures
| Measure |
Arm 1 (MTD Cohort Number)
n=12 Participants
Cohort1= VOR 300mg/day D1-14, Cohort 2=VOR 400 mg/day D1-14, Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 (MTD Cohort Number)
n=12 Participants
CBT: Cohort1= AUC4 D1; Cohort2= AUC5 D1; Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A (MTD Cohort Number)
n=19 Participants
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Cohort3=Vor 300mg/day x14 days; CBT AUC5 Cohort4=Vor 300 mg/day x14 days; CBT AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B (MTD Cohort Number)
n=9 Participants
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
2 cohort number
|
2 cohort number
|
4 cohort number
|
2 cohort number
|
PRIMARY outcome
Timeframe: two patients withdrew consents and one pt chose not to proceed with treatmentPopulation: two patients withdrew consents and one pt chose not to proceed with treatment
Phase II of the trial has never opened d/t Sponsor's withdrawal of the funding
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1 Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1 Cohort 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2 Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 2 Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2 Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3A Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 3A Cohort 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Arm 3A Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 3A Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3B Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3B Cohort 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1 Cohort 1
n=3 participants at risk
Cohort1= VOR 300mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 2
n=3 participants at risk
Cohort 2=VOR 400 mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 3
n=8 participants at risk
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 1
n=6 participants at risk
CBT: Cohort1= AUC4 D1;
Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 2
n=3 participants at risk
CBT: Cohort2= AUC5 D1;
Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 3
n=3 participants at risk
CBT: Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A Cohort 1
n=5 participants at risk
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 2
n=6 participants at risk
Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 3
n=5 participants at risk
Cohort3=Vor 300mg/day x14 days; CBT AUC5 Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 4
n=3 participants at risk
Cohort4=Vor 300 mg/day x14 days; CBTP AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B Cohort 1
n=3 participants at risk
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
Arm 3B Cohort 2
n=7 participants at risk
Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/8 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/7 • 65 months
|
|
General disorders
Death
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/8 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/5 • 65 months
|
16.7%
1/6 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
14.3%
1/7 • 65 months
|
Other adverse events
| Measure |
Arm 1 Cohort 1
n=3 participants at risk
Cohort1= VOR 300mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 2
n=3 participants at risk
Cohort 2=VOR 400 mg/day D1-14, Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 1 Cohort 3
n=8 participants at risk
Cohort 3=VOR 500mg/day D1-14; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 1
n=6 participants at risk
CBT: Cohort1= AUC4 D1;
Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 2
n=3 participants at risk
CBT: Cohort2= AUC5 D1;
Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 2 Cohort 3
n=3 participants at risk
CBT: Cohort3= AUC6 D1; Each Cohort also had set cRA 100mg/m2/day D1-21
|
Arm 3A Cohort 1
n=5 participants at risk
Cohort1=Vor 400 mg/day x14 days; CBT AUC 6; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 2
n=6 participants at risk
Cohort2=Vor 400 mg; /day x14 days; CBT AUC 5; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 3
n=5 participants at risk
Cohort3=Vor 300mg/day x14 days; CBT AUC5 Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3A Cohort 4
n=3 participants at risk
Cohort4=Vor 300 mg/day x14 days; CBTP AUC 4; Each Cohort also had set cRA 100 mg/m2/day x 21 days
|
Arm 3B Cohort 1
n=3 participants at risk
Cohort 1=Vor 400 mg/day, D 1-7 \& 15-21; Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
Arm 3B Cohort 2
n=7 participants at risk
Cohort 2=Vor 500 mg/day, D 1-7 \& 15-21 Each Cohort also had set cRA 100 mg/m2/day, D 1-21 \& TMZ 150 mg/m2/day, D 1-7 \&15-21"
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
3/3 • 65 months
|
100.0%
3/3 • 65 months
|
75.0%
6/8 • 65 months
|
33.3%
2/6 • 65 months
|
100.0%
3/3 • 65 months
|
100.0%
3/3 • 65 months
|
60.0%
3/5 • 65 months
|
83.3%
5/6 • 65 months
|
80.0%
4/5 • 65 months
|
66.7%
2/3 • 65 months
|
100.0%
3/3 • 65 months
|
85.7%
6/7 • 65 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
25.0%
2/8 • 65 months
|
33.3%
2/6 • 65 months
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
20.0%
1/5 • 65 months
|
33.3%
2/6 • 65 months
|
80.0%
4/5 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
14.3%
1/7 • 65 months
|
|
Blood and lymphatic system disorders
Platelets count decreased
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
62.5%
5/8 • 65 months
|
50.0%
3/6 • 65 months
|
66.7%
2/3 • 65 months
|
66.7%
2/3 • 65 months
|
80.0%
4/5 • 65 months
|
66.7%
4/6 • 65 months
|
60.0%
3/5 • 65 months
|
66.7%
2/3 • 65 months
|
100.0%
3/3 • 65 months
|
71.4%
5/7 • 65 months
|
|
Cardiac disorders
Cholesterol Elevated
|
66.7%
2/3 • 65 months
|
66.7%
2/3 • 65 months
|
62.5%
5/8 • 65 months
|
100.0%
6/6 • 65 months
|
33.3%
1/3 • 65 months
|
66.7%
2/3 • 65 months
|
100.0%
5/5 • 65 months
|
100.0%
6/6 • 65 months
|
80.0%
4/5 • 65 months
|
100.0%
3/3 • 65 months
|
66.7%
2/3 • 65 months
|
42.9%
3/7 • 65 months
|
|
Cardiac disorders
Dyspnea
|
66.7%
2/3 • 65 months
|
33.3%
1/3 • 65 months
|
12.5%
1/8 • 65 months
|
16.7%
1/6 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/5 • 65 months
|
16.7%
1/6 • 65 months
|
0.00%
0/5 • 65 months
|
66.7%
2/3 • 65 months
|
33.3%
1/3 • 65 months
|
42.9%
3/7 • 65 months
|
|
Gastrointestinal disorders
Alopecia
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/8 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/7 • 65 months
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
50.0%
4/8 • 65 months
|
33.3%
2/6 • 65 months
|
66.7%
2/3 • 65 months
|
0.00%
0/3 • 65 months
|
20.0%
1/5 • 65 months
|
16.7%
1/6 • 65 months
|
20.0%
1/5 • 65 months
|
0.00%
0/3 • 65 months
|
100.0%
3/3 • 65 months
|
57.1%
4/7 • 65 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
37.5%
3/8 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/3 • 65 months
|
66.7%
2/3 • 65 months
|
40.0%
2/5 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/5 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
28.6%
2/7 • 65 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
37.5%
3/8 • 65 months
|
66.7%
4/6 • 65 months
|
33.3%
1/3 • 65 months
|
66.7%
2/3 • 65 months
|
40.0%
2/5 • 65 months
|
16.7%
1/6 • 65 months
|
100.0%
5/5 • 65 months
|
33.3%
1/3 • 65 months
|
66.7%
2/3 • 65 months
|
71.4%
5/7 • 65 months
|
|
Gastrointestinal disorders
Vomitting
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
12.5%
1/8 • 65 months
|
16.7%
1/6 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
40.0%
2/5 • 65 months
|
16.7%
1/6 • 65 months
|
60.0%
3/5 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
14.3%
1/7 • 65 months
|
|
Metabolism and nutrition disorders
ALT elevated
|
0.00%
0/3 • 65 months
|
66.7%
2/3 • 65 months
|
25.0%
2/8 • 65 months
|
16.7%
1/6 • 65 months
|
33.3%
1/3 • 65 months
|
66.7%
2/3 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/6 • 65 months
|
20.0%
1/5 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
14.3%
1/7 • 65 months
|
|
Metabolism and nutrition disorders
AST elevated
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
25.0%
2/8 • 65 months
|
16.7%
1/6 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/6 • 65 months
|
40.0%
2/5 • 65 months
|
33.3%
1/3 • 65 months
|
33.3%
1/3 • 65 months
|
28.6%
2/7 • 65 months
|
|
Nervous system disorders
Fatigue
|
100.0%
3/3 • 65 months
|
66.7%
2/3 • 65 months
|
50.0%
4/8 • 65 months
|
66.7%
4/6 • 65 months
|
100.0%
3/3 • 65 months
|
100.0%
3/3 • 65 months
|
100.0%
5/5 • 65 months
|
16.7%
1/6 • 65 months
|
60.0%
3/5 • 65 months
|
33.3%
1/3 • 65 months
|
66.7%
2/3 • 65 months
|
85.7%
6/7 • 65 months
|
|
Nervous system disorders
Insomnia
|
66.7%
2/3 • 65 months
|
33.3%
1/3 • 65 months
|
25.0%
2/8 • 65 months
|
50.0%
3/6 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
20.0%
1/5 • 65 months
|
0.00%
0/6 • 65 months
|
20.0%
1/5 • 65 months
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
14.3%
1/7 • 65 months
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/8 • 65 months
|
16.7%
1/6 • 65 months
|
33.3%
1/3 • 65 months
|
0.00%
0/3 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/6 • 65 months
|
0.00%
0/5 • 65 months
|
0.00%
0/3 • 65 months
|
33.3%
1/3 • 65 months
|
14.3%
1/7 • 65 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
100.0%
3/3 • 65 months
|
33.3%
1/3 • 65 months
|
37.5%
3/8 • 65 months
|
83.3%
5/6 • 65 months
|
66.7%
2/3 • 65 months
|
33.3%
1/3 • 65 months
|
60.0%
3/5 • 65 months
|
0.00%
0/6 • 65 months
|
80.0%
4/5 • 65 months
|
66.7%
2/3 • 65 months
|
66.7%
2/3 • 65 months
|
42.9%
3/7 • 65 months
|
Additional Information
Dr. Vinay K. Puduvalli
University of Texas M D Anderson Cancer Center
Phone: (713) 745-2343
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place