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) (ECLIPSE)
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.
|Squamous Cell Lung Cancer||Drug: gemcitabine/carboplatin Drug: gemcitabine/carboplatin plus Iniparib||Phase 3|
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- overall survival [ Time Frame: 12 months, 24 months ]
- progression free survival [ Time Frame: 12 months ]
|Study Start Date:||March 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: gemcitabine/carboplatin||
|Experimental: gemcitabine/carboplatin plus Iniparib||
Drug: gemcitabine/carboplatin plus Iniparib
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082549
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|Study Director:||Clinical Sciences & Operations||Sanofi|