A Study of Oral Rucaparib in Patients With gBRCA Mutation Breast or Ovarian Cancer, or Other Solid Tumor

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Solid Tumor/Phase I, Breast: Metastatic
NCT ID: NCT01482715 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-048

 

The purpose of the first part of the study is to evaluate the safety of different doses of oral rucaparib given daily to patients with solid tumors. The purpose of the second part of the study is to determine the safety and clinical activity of oral rucaparib given daily to patients with locally advanced or metastatic breast cancer associated with a germline breast cancer (gBRCA) mutation and to patients with platinum-sensitive relapsed ovarian cancer associated with a gBRCA mutation who have received at least two, but no more than three, prior regimens (all platinum based).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: (PART 1) - Adequate bone marrow, hepatic (liver), renal, and cardiac function - Locally recurrent or metastatic solid tumor (includes lymphoma, all types of breast cancer) that has progressed on standard treatment OR (PART 2) - Locally advanced or metastatic breast cancer associated with a gBRCA mutation and that has relapsed following prior treatment, is not HER2+, and is measurable - Ovarian cancer associated with a gBRCA mutation that has relapsed >6 months following platinum-based prior treatment and is measurable Exclusion Criteria: (ALL) - History of prior cancer except for non-melanoma skin cancer, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer - Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible. - Untreated or symptomatic central nervous system metastases - Impaired cardiac function or clinically significant cardiac disease
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