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Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

NCT01082549•Sanofi

View on ClinicalTrials.gov

Summary

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligible patients must meet the following criteria to be enrolled in the study:
•1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system).

Exclusion Criteria

•5. Presence of evaluable (measureable or non-measurable) disease.
•6. ECOG Performance Status of 0 or 1.
•7. Laboratory values as follows:
•* Absolute neutrophil count (ANC) \>1,500/microL and platelets \>100,000/microL (≤72 hours prior to initial treatment).
•* Hemoglobin \>9 g/dL (Note: Patients may be transfused or receive erythropoietin to maintain or exceed this level).
•* Bilirubin \< ULN.
•* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement.
•* Creatinine \<2.0 mg/dL, or creatinine clearance \>40 mL/min (as calculated by the Cockcroft-Gault method.
•8. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Sexually active men must agree to use a medically acceptable form of birth control during treatment and at least 6 months after the last dose. If a female partner becomes pregnant during the course of the study the treating physician should be informed immediately.
•9. \>18 years of age.
+19 more criteria

Locations (142)

Investigational Site Number 840306

Birmingham, Alabama, United States

Investigational Site Number 840207

Huntsville, Alabama, United States

Investigational Site Number 840351

Muscle Shoals, Alabama, United States

Investigational Site Number 840338

Anaheim, California, United States

Investigational Site Number 840353

Burbank, California, United States

Investigational Site Number 840341

Concord, California, United States

Investigational Site Number 840317

Duarte, California, United States

Investigational Site Number 840339

La Verne, California, United States

Investigational Site Number 840309

Loma Linda, California, United States

Investigational Site Number 840307

Los Angeles, California, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

March 17, 2016

Enrollment

780

ACTUAL participants

Conditions

Squamous Cell Lung Cancer

Interventions

gemcitabine/carboplatin

DRUG

gemcitabine/carboplatin plus Iniparib

DRUG

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

NCT05607108

Squamous Cell Lung Cancer

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

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