Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase 1 Study of PARP Inhibitor BMN 673 and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
This phase I trial studies the side effects and best dose of talazoparib and heat shock protein (HSP)90 inhibitor AT13387 when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or ovarian, fallopian tube, primary peritoneal, or hormone negative breast cancer that have come back after a period of improvement (recurrent). Talazoparib and HSp90 inhibitor AT13387 may stop the growth of tumor cells by blocking some enzymes that are need for cell growth. HSp90 inhibitor AT1338 may also help talazoparib work better by making tumor cells more sensitive to the drug.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTDs) of BMN673 (talazoparib) and AT13387 (HSP90
Inhibitor AT13387) administered in combination in patients with advanced solid tumors.
SECONDARY OBJECTIVES:
I. To identify the dose-limiting toxicity (DLT) and other toxicities associated with BMN673
and AT13387 administered in combination as assessed by Common Terminology Criteria for
Adverse Events (CTCAE) version (v) 4.0.
II. To determine the recommended phase 2 doses (RP2D) of the combination of BMN673 and
AT13387.
III. To determine the plasma pharmacokinetics of BMN673 and AT13387. IV. To document
anti-tumor activity of the combination of BMN673 and AT13387 as assessed by (Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression free survival (PFS).
OUTLINE: This is a dose-escalation study.
Patients receive talazoparib orally (PO) once daily (QD) on days 1-7 (course 0). Beginning
in course 1, patients receive talazoparib PO QD on days 1-28 and HSP90 inhibitor AT13387
intravenously (IV) over 1 hour on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 3
months for up to 2 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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