EUCTR2016-000816-14-PL
Active, not recruiting
Phase 1
ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): Phase 3 Multicenter, Randomized Study of Rucaparib versus Chemotherapy in Patients with Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - ARIEL4
ConditionsRelapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal CancerMedDRA version: 20.0Level: PTClassification code 10038977Term: Retroperitoneal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Sponsor
- Clovis Oncology, Inc.
- Enrollment
- 345
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Be 18 years of age at the time the informed consent form is signed.
- •2\.Have a histologically confirmed diagnosis of high\-grade serous or Grade 2 or Grade 3 endometroid epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- •3\.Received \= 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment.
- •4\.Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation.
- •5\.Have sufficient archival formalin\-fixed paraffin\-embedded (FFPE) tumor tissue available for planned analyses.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 310
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.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).
- •2\.Prior treatment with any PARP inhibitor.
- •3\.Symptomatic and/or untreated central nervous system metastases.
- •4\.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.
- •5\.Women who are pregnant or breast feeding.
- •6\.Hospitalization for bowel obstruction within 3 months prior to enrollment.
Outcomes
Primary Outcomes
Not specified
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