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

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