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NCT01593228 · ClinicalTrials.gov registry record · Phase 3

Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
37
Enrollment target

NCT01593228: Completed Phase 3 study, sponsored by Sanofi.

NCT01593228 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 37 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01593228, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
37 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.

Interventions

  • DRUG Carboplatin
  • DRUG Gemcitabine
  • DRUG Irinotecan
  • DRUG Iniparib (SAR240550/BSI-201)
  • DRUG Doxorubicin HCL liposome injection

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2012-05
Est. Completion 2016-09
Phase Phase 3
Sanofi

713 total trials

What the finished NCT01593228 record still lists

NCT01593228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT01593228 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01593228 about?

NCT01593228 is a clinical study titled "Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial". The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.

What is the current status of trial NCT01593228?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2012-05. Estimated completion is 2016-09.

What interventions are being tested in trial NCT01593228?

The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Irinotecan (DRUG), Iniparib (SAR240550/BSI-201) (DRUG), Doxorubicin HCL liposome injection (DRUG).

Who is sponsoring clinical trial NCT01593228?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01593228's enrollment target sits among peer trials

37 1901st of 2000 higher than 100 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01593228, the US trial registry maintained by the National Library of Medicine. NCT01593228 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.