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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 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.

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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.

Interventions

  • DRUG Iniparib

Study Locations (1)

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2008-06
Est. Completion 2008-12
Phase Phase 2

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00677079

The ClinicalTrials.gov registry entry for NCT00677079 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 152-participant average among 27 other Primary Peritoneal Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.