Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02152982
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2014-05-27
Brief Title:
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIIII Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase IIIII trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme
Detailed Description:
PRIMARY OBJECTIVE
I Test whether the experimental combination of ABT-888 veliparib combined with TMZ temozolomide compared to the control of placebo combined with TMZ significantly extends overall survival in newly diagnosed glioblastoma multiforme GBM patients with tumor MGMT promoter hypermethylation
SECONDARY OBJECTIVES
I Test whether the experimental treatment significantly extends progression-free survival
II Test whether the experimental treatment improves objective tumor response III Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events
CORRELATIVE SCIENCE OBJECTIVES
I Evaluate the utility of dynamic susceptibility contrast DSC and diffusion weighted imaging DWI magnetic resonance imaging MRI techniques in defining time to progression in the setting of a large multi-institutional clinical trial
II Test the concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status in cases with local testing
III Evaluate whether genetic or epigenetic alterations in deoxyribonucleic acid DNA repair or replication genes are associated with overall survival progression-free survival and objective tumor response
IV Test whether polymorphisms in MGMT PARP1 or other DNA repair proteins are associated with overall survival progression-free survival objective tumor response or rates of grade 3 or higher adverse events
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive temozolomide orally PO once daily QD on days 1-5 and veliparib PO twice daily BID on days 1-7 Treatment repeats every 28 days for 6 cycles in the absence of disease progression confirmed progression or unacceptable toxicity
ARM II Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7 Treatment repeats every 28 days for 6 cycles in the absence of disease progression confirmed progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 3 years every 6 months for 2 years
I Test whether the experimental combination of ABT-888 veliparib combined with TMZ temozolomide compared to the control of placebo combined with TMZ significantly extends overall survival in newly diagnosed glioblastoma multiforme GBM patients with tumor MGMT promoter hypermethylation
SECONDARY OBJECTIVES
I Test whether the experimental treatment significantly extends progression-free survival
II Test whether the experimental treatment improves objective tumor response III Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events
CORRELATIVE SCIENCE OBJECTIVES
I Evaluate the utility of dynamic susceptibility contrast DSC and diffusion weighted imaging DWI magnetic resonance imaging MRI techniques in defining time to progression in the setting of a large multi-institutional clinical trial
II Test the concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status in cases with local testing
III Evaluate whether genetic or epigenetic alterations in deoxyribonucleic acid DNA repair or replication genes are associated with overall survival progression-free survival and objective tumor response
IV Test whether polymorphisms in MGMT PARP1 or other DNA repair proteins are associated with overall survival progression-free survival objective tumor response or rates of grade 3 or higher adverse events
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive temozolomide orally PO once daily QD on days 1-5 and veliparib PO twice daily BID on days 1-7 Treatment repeats every 28 days for 6 cycles in the absence of disease progression confirmed progression or unacceptable toxicity
ARM II Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7 Treatment repeats every 28 days for 6 cycles in the absence of disease progression confirmed progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 3 years every 6 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-00616 | REGISTRY | None | None |
| A071102 | None | None | None |
| CALGB-A071102 | None | None | None |
| A071102 | OTHER | None | None |
| A071102 | OTHER | None | None |
| P50CA108961 | NIH | None | None |
| U10CA180821 | NIH | None | None |
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |