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A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Not Recruiting
Trial ID: NCT01891344
Purpose
The purpose of this study is to determine which patients with ovarian, fallopian tube, and
primary peritoneal cancer will best respond to treatment with rucaparib.
Official Title
A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Stanford Investigator(s)
Eligibility
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
- Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3
endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and
maintenance therapies administered as single agent treatment will not count as a
chemotherapy regimen
- Relapsed/progressive disease as confirmed by CT scan
- Have biopsiable and measurable disease. Note: biopsy is optional for patients known to
harbor a deleterious gBRCA mutation
- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue
available for planned analyses
Exclusion:
- History of prior cancers except for those that have been curatively treated, with no
evidence of cancer currently (provided all chemotherapy was completed >6 months prior
and/or bone marrow transplant >2 years prior to first dose of rucaparib).
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that
would, in the opinion of the Investigator, interfere with absorption of rucaparib
- Hospitalization for bowel obstruction within 3 months prior to enrollment
Intervention(s):
drug: Oral rucaparib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061