A study to test efficacy of Rucaparib in patients with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 1

• Conditions: Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; MedDRA 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]

• Registration Number: EUCTR2016-000816-14-PL
• Lead Sponsor: Clovis Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 345

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
F.1.3.1 Number of subjects for this age range 35

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified