Tumors Clinical Trial
Official title:
A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose
(MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult
subjects with histologically documented advanced solid tumors that are refractory to
standard therapy or for which no standard therapy is available. Additionally, the safety and
tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients
with metastatic breast cancer in the phase 1b portion of the study.
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
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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