Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma

This study has been completed.

Sponsor:

Collaborators:

National Cancer Institute (NCI)

NRG Oncology

Information provided by (Responsible Party):

Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier:

NCT01026493

First received: December 3, 2009

Last updated: June 2, 2017

Last verified: June 2017

History of Changes

Results First Received: January 17, 2017

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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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

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1. Primary:

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

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2. Primary:

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

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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.) ]

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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.) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
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
Study First Received:	December 3, 2009
Results First Received:	January 17, 2017
Last Updated:	June 2, 2017

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