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About
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin.
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.
Enrollment
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Inclusion criteria
Exclusion criteria
Concurrent invasive malignancy, not including:
Lesions identifiable only by positron emission tomography (PET)
Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201
Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)
Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia
Enrollment in another investigational device or drug study, or current treatment with other investigational agents
Concurrent radiation therapy to treat primary disease throughout the course of the study
Inability to comply with the requirements of the study
Pregnancy or lactation
Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
Primary purpose
Allocation
Interventional model
Masking
43 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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