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Summary

for females ages 18 years and up
at San Francisco, California and other locations
study started

Description

Summary

Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Currently Enrolling) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).

Official Title

A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

Details

Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) 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 recombination [HR] DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies.

An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations. For this study, it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation, thereby limiting tumor progression and providing therapeutic benefit.

Keywords

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Advanced Solid Tumor With Evidence of Germline or Somatic BRCA gBRCA ovarian cancer platinum sensitive PARP Inhibitor Rucaparib CO-338 PF 01367338 AG 14699 BRCA1 BRCA2 platinum sensitive ovarian cancer platinum sensitive gBRCA ovarian cancer gynecological cancer relapsed disease homologous recombination deficiency HRD

Eligibility

For females ages 18 years and up

The following eligibility criteria below pertain to patients enrolling into Part 2B of the study.

Inclusion Criteria:

  • Have a known deleterious BRCA mutation (gBRCA or sBRCA) (as determined by a local laboratory that has received an international or country-specific, quality standards certification)
  • Have evidence of measurable disease as defined by RECIST Version 1.1
  • Have sufficient archival FFPE tumor tissue available for planned analyses. Archival tissue from the most recently collected biopsy or debulking surgery should be provided, if available.
  • Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment

Exclusion Criteria:

  • Active second malignancy, i.e., patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment

    a. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed>6 months prior and/or bone marrow transplant (BMT)>2 years prior to first dose of rucaparib

  • Prior treatment with any PARP inhibitor.
  • Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
  • Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs 14 days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment> NCI CTCAE Grade 1 (Grade 2 non-hematologic toxicity to most recent treatment may be permitted with prior advanced approval from Sponsor).
  • Hospitalization for bowel obstruction within 3 months prior to enrollment.

Locations

  • Sarah Cannon Research Institute
    Nashville, Tennessee, 37203, United States
  • Princess Margaret Cancer Centre
    Toronto, Ontario, MSG 2M9, Canada
  • Karmanos Cancer Institute
    Detroit, Michigan, 48201, United States
  • Sarah Cannon Research Institute
    Sarasota, Florida, 34232, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania, 19104, United States
  • Dana-Farber Cancer Institute (Part 3 only)
    Boston, Massachusetts, 02215, United States
  • Guy's and St Thomas NHS Foundation Trust
    London, England, SE1 9RT, United Kingdom
  • Royal Marsden NHS Foundation Trust
    London, England, SW3 6JJ, United Kingdom
  • Imperial College Healthcare
    London, England, W12 0HS, United Kingdom
  • Newcastle University
    Newcastle Upon Tyne, England, UK NE7, United Kingdom
  • Institution of Cancer Science, University of Glasgow Wolfson Wohl Cancer Research
    Glasgow, Scotland, G61 1QH, United Kingdom
  • University College London Cancer Institute
    London, WC1E 6BT, United Kingdom
  • Hospital Vall d'Hebron
    Barcelona, 8035, Spain
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 632394, Israel

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Clovis Oncology, Inc.
ID
NCT01482715
Phase
Phase 1/2
Study Type
Interventional
Last Updated
June 1, 2017