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SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer

NCT01086254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2013-09-24

No results posted yet for this study

Summary

Primary Objective:

* to assess the objective response rate (ORR) of Iniparib (SAR240550) administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (GCS) as well as with the standard regimen of gemcitabine/cisplatin (GC) in patients with stage IV non small cell lung cancer.

Secondary objectives are:

* to assess the safety profiles of the study combination GCS and of the standard regimen GC;
* to assess the progression free survival and the overall survival in both arms;
* to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease.
* to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells (PBMC). (As of 10 September 2010, the collection of PBMC is temporarily discontinued.)

Conditions

  • Non-small Cell Lung Cancer Stage IV

Interventions

DRUG

Iniparib

Pharmaceutical form: solution for infusion Route of administration: 60-minute IV infusion

DRUG

gemcitabine

Pharmaceutical form: solution for infusion Route of administration: 30-minute IV infusion

DRUG

cisplatin

Pharmaceutical form: solution for infusion Route of administration: 1- to 4-hour IV infusion, according to the local standard

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01086254 on ClinicalTrials.gov