Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01026493 |
Recruitment Status :
Completed
First Posted : December 4, 2009
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
|
Sponsor:
Radiation Therapy Oncology Group
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Brain and Central Nervous System Tumors |
Interventions |
Drug: temozolomide 60 mg x 21 days Drug: temozolomide 75 mg x 21 days Drug: ABT-888 20 mg x 21 days Drug: ABT-888 40 mg x 21 days Drug: Temozolomide 150 mg x 5 days Drug: ABT-888 40 mg x 5 days |
Enrollment | 257 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Phase I: Dose Level 1 | Phase I: Dose Level 2a | Phase I: Dose Level 2b | Phase I: Dose Level 3 | Phase II: Arm 1/BEV-NAIVE | Phase II: Arm 2/BEV-NAIVE | Phase II: Arm 1/BEV-FAILURE | Phase II: Arm 2/BEV-FAILURE |
---|---|---|---|---|---|---|---|---|
![]() |
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days | ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days | ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days | ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days | ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days |
Period Title: Overall Study | ||||||||
Started | 8 [1] | 7 | 9 | 8 | 75 | 76 | 36 | 38 |
Completed | 8 | 6 | 9 | 8 | 73 | 73 | 32 | 37 |
Not Completed | 0 | 1 | 0 | 0 | 2 | 3 | 4 | 1 |
Reason Not Completed | ||||||||
Protocol Violation | 0 | 1 | 0 | 0 | 2 | 3 | 4 | 1 |
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
|
Baseline Characteristics
Arm/Group Title | Phase I: Dose Level 1 | Phase I: Dose Level 2a | Phase I: Dose Level 2b | Phase I: Dose Level 3 | Phase II: Arm 1/BEV-NAIVE | Phase II: Arm 2/BEV-NAIVE | Phase II: Arm 1/BEV-FAILURE | Phase II: Arm 2/BEV-FAILURE | Total | |
---|---|---|---|---|---|---|---|---|---|---|
![]() |
ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days | ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days | ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days | ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days | ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days | ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days | Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 6 | 9 | 8 | 73 | 73 | 32 | 37 | 246 | |
![]() |
Eligible patients
|
|||||||||
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||||||||
Number Analyzed | 8 participants | 6 participants | 9 participants | 8 participants | 73 participants | 73 participants | 32 participants | 37 participants | 246 participants | |
48
(20 to 63)
|
51
(48 to 63)
|
53
(18 to 67)
|
41
(20 to 81)
|
56
(21 to 77)
|
56
(20 to 81)
|
56
(20 to 70)
|
57
(38 to 77)
|
56
(18 to 81)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 8 participants | 6 participants | 9 participants | 8 participants | 73 participants | 73 participants | 32 participants | 37 participants | 246 participants | |
Female |
2 25.0%
|
1 16.7%
|
5 55.6%
|
4 50.0%
|
20 27.4%
|
26 35.6%
|
12 37.5%
|
14 37.8%
|
84 34.1%
|
|
Male |
6 75.0%
|
5 83.3%
|
4 44.4%
|
4 50.0%
|
53 72.6%
|
47 64.4%
|
20 62.5%
|
23 62.2%
|
162 65.9%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: | Wendy Seiferheld, M.S. |
Organization: | NRG Oncology |
EMail: | seiferheldw@nrgoncology.org |
Responsible Party: | Radiation Therapy Oncology Group |
ClinicalTrials.gov Identifier: | NCT01026493 |
Other Study ID Numbers: |
RTOG-0929 CDR0000660545 |
First Submitted: | December 3, 2009 |
First Posted: | December 4, 2009 |
Results First Submitted: | January 17, 2017 |
Results First Posted: | July 2, 2017 |
Last Update Posted: | July 2, 2017 |