Uterine Carcinosarcoma Clinical Trial
Official title:
A Phase II Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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