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NCT01506609 · ClinicalTrials.gov registry record · Phase 2
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 (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 294
- Enrollment target
NCT01506609: Completed Phase 2 study, sponsored by AbbVie.
NCT01506609 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 294 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (121% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01506609, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 294 participants
- Enrollment target
Study 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.
Primary Outcome
PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Paclitaxel
- DRUG Temozolomide
- DRUG Veliparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2012-01-23 |
| Est. Completion | 2020-09-02 |
| Phase | Phase 2 |
What the finished NCT01506609 record still lists
NCT01506609 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (121% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01506609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01506609 about?
NCT01506609 is a clinical study titled "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 (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer". 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 metast...
What is the current status of trial NCT01506609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 294 participants. The study started on 2012-01-23. Estimated completion is 2020-09-02.
What interventions are being tested in trial NCT01506609?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Paclitaxel (DRUG), Temozolomide (DRUG), Veliparib (DRUG).
Who is sponsoring clinical trial NCT01506609?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01506609's enrollment target sits among peer trials
294 190th of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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