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)
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|ClinicalTrials.gov Identifier: NCT01082549|
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : March 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Lung Cancer||Drug: gemcitabine/carboplatin Drug: gemcitabine/carboplatin plus Iniparib||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||780 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
|Active Comparator: gemcitabine/carboplatin||
|Experimental: gemcitabine/carboplatin plus Iniparib||
Drug: gemcitabine/carboplatin plus Iniparib
- overall survival [ Time Frame: 12 months, 24 months ]
- progression free survival [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082549
|Study Director:||Clinical Sciences & Operations||Sanofi|