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NCT00677079 · ClinicalTrials.gov registry record · Phase 2
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study of Primary Peritoneal Cancer and Advanced Epithelial Ovarian Cancer, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00677079: Completed Phase 2 study of Primary Peritoneal Cancer and Advanced Epithelial Ovarian Cancer, sponsored by Sanofi.
NCT00677079 is a Phase 2 study of Primary Peritoneal Cancer and Advanced Epithelial Ovarian Cancer that has completed, run by Sanofi. The registered enrollment target is 12 participants, below the 152-participant average among 27 other Primary Peritoneal Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00677079, a Phase 2 study of Primary Peritoneal Cancer and Advanced Epithelial Ovarian Cancer, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
Primary Outcome
Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
Conditions Studied
Interventions
- DRUG Iniparib
Study Locations (1)
New York
- - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00677079 record still lists
NCT00677079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 152-participant average among 27 other Primary Peritoneal Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Primary Peritoneal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Iniparib is the first listed.
NCT00677079 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00677079 about?
NCT00677079 is a clinical study titled "Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patient...
What is the current status of trial NCT00677079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2008-06. Estimated completion is 2008-12.
What conditions does trial NCT00677079 study?
This clinical trial studies the following conditions: Primary Peritoneal Cancer, Advanced Epithelial Ovarian Cancer.
What interventions are being tested in trial NCT00677079?
The interventions under investigation include: Iniparib (DRUG).
Who is sponsoring clinical trial NCT00677079?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00677079 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Peritoneal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00677079's enrollment target sits among peer trials
12 27th of 27 higher than 1 of 27 other Primary Peritoneal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Peritoneal Cancer 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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