Status:
COMPLETED
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Lead Sponsor:
pharmaand GmbH
Collaborating Sponsors:
Foundation Medicine
Myriad Genetics, Inc.
Conditions:
Ovarian Cancer
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous rec...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT01891344
Start Date
October 30 2013
End Date
September 28 2021
Last Update
June 12 2023
Active Locations (75)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
3
Saint Jude Heritage Medical Center
Fullerton, California, United States, 92835
4
University of California Los Angeles
Los Angeles, California, United States, 90404