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

NCT01593228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-09-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

Iniparib (SAR240550/BSI-201)

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Carboplatin

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Doxorubicin HCL liposome injection

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Gemcitabine

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Irinotecan

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Paclitaxel

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Topotecan

Pharmaceutical form:Solution Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States
  • Belgium
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593228 on ClinicalTrials.gov