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Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma

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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:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase I: Dose Level 1 ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
Phase I: Dose Level 2a ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
Phase I: Dose Level 2b ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
Phase I: Dose Level 3 ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
Phase II: Arm 1/BEV-NAIVE ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
Phase II: Arm 2/BEV-NAIVE ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
Phase II: Arm 1/BEV-FAILURE ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
Phase II: Arm 2/BEV-FAILURE ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days

Participant Flow:   Overall Study
    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
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 
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients

Reporting Groups
  Description
Phase I: Dose Level 1 ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
Phase I: Dose Level 2a ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
Phase I: Dose Level 2b ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
Phase I: Dose Level 3 ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
Phase II: Arm 1/BEV-NAIVE ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
Phase II: Arm 2/BEV-NAIVE ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
Phase II: Arm 1/BEV-FAILURE ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
Phase II: Arm 2/BEV-FAILURE ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 		 8   6   9   8   73   73   32   37   246 
Age 
[Units: Years]
Median (Full Range) 		 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 
[Units: Participants]
Count of 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

1.  Primary:   Phase 1: Maximum Tolerated Dose (MTD)   [ Time Frame: Start of treatment to 8 weeks. ]
  Show Outcome Measure 1

2.  Primary:   Phase II: 6-month Progression-free Survival (PFS) Rate for Patients With Measurable Disease After Surgery   [ Time Frame: Randomization to 6 months. ]
  Show Outcome Measure 2

3.  Secondary:   Phase II: Objective Response (Partial and Complete Response) Rate for Patients With Measurable Disease After Surgery   [ Time Frame: Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.) ]
  Show Outcome Measure 3

4.  Secondary:   Phase II: Overall Survival (OS)   [ Time Frame: Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.) ]
  Show Outcome Measure 4


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01026493     History of Changes
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