A Phase 2 interventional study of paclitaxel and carboplatin in Uterine Carcinosarcoma, sponsored by Sanofi. Completed at 40 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas.
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.
Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Participants will be administered pacitaxel, carboplatin and BSI-201 (Iniparib) in 21 day treatment cycles. Treatment will continue until disease progression or adverse effects prohibit further therapy.
Drug: paclitaxel · Drug: carboplatin · Drug: BSI-201 (Iniparib)
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days).
Also known as: SAR204550
Clinical response rate
Time frame: 6 months
The record gives a start of May 2008, a primary completion of Mar 2010 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Paclitaxel · Carboplatin · Iniparib