Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01506609
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2012-01-06
Brief Title:
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide TMZ or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03123211
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
The primary objective of the study is to assess the progression-free survival PFS of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-002913-12 | EUDRACT_NUMBER | None | None |