Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01540565
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2012-02-22
Brief Title:
Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of the Poly ADP-Ribose Polymerase PARP-1 and -2 Inhibitor Veliparib ABT-888 NSC737664 in the Treatment of Persistent or Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation
Status:
COMPLETED
Status Verified Date:
2019-07
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 phase II trial studies how well veliparib works in treating patients with epithelial ovarian fallopian tube or primary peritoneal cancer that has come back or does not respond to treatment Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the proportion of patients who have objective tumor response complete or partial
II To determine the frequency and severity of adverse events associated with treatment with veliparib ABT-888 as assessed by the Active Version of the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 40
SECONDARY OBJECTIVES
I To determine the duration of progression-free survival PFS and overall survival OS
II To determine the proportion of patients who survive progression-free for at least 6 months
TERTIARY OBJECTIVES
I To explore the association between single nucleotide polymorphisms SNPs in deoxyribonucleic acid DNA repair genes eg breast cancer BRCA1 Fanconi and clinical characteristics response and patient outcome PFS and OS
OUTLINE
Patients receive veliparib orally PO twice daily BID on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I To estimate the proportion of patients who have objective tumor response complete or partial
II To determine the frequency and severity of adverse events associated with treatment with veliparib ABT-888 as assessed by the Active Version of the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 40
SECONDARY OBJECTIVES
I To determine the duration of progression-free survival PFS and overall survival OS
II To determine the proportion of patients who survive progression-free for at least 6 months
TERTIARY OBJECTIVES
I To explore the association between single nucleotide polymorphisms SNPs in deoxyribonucleic acid DNA repair genes eg breast cancer BRCA1 Fanconi and clinical characteristics response and patient outcome PFS and OS
OUTLINE
Patients receive veliparib orally PO twice daily BID on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-00684 | REGISTRY | None | None |
| S12-02446 | None | None | None |
| GOG-0280 | None | None | None |
| CDR0000726699 | None | None | None |
| GOG-0280 | OTHER | None | None |
| GOG-0280 | OTHER | None | None |
| U10CA180868 | NIH | None | None |