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BRIEF TITLE: Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

  • Org Study ID: CO-338-100
  • Secondary ID:
  • NCT ID: NCT04171700
  • NCT Alias:
  • Sponsor: Clovis Oncology, Inc. - Industry
  • Source: Clovis Oncology, Inc.

Brief Summary

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

Overal Status Start Date Phase Study Type
Recruiting November 21, 2019 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Best Overall Response Rate by Investigator

Primary Outcome 1 - Time Frame: From first dose of study drug until disease progression (up to approximately 2 years)


  • Solid Tumor


Key Inclusion Criteria:

- Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive

- Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate

- Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C,
RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that
are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with
epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or
metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are
ineligible for this trial.

- At least one prior line of therapy extending overall survival or standard of care
therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion
criteria for previous treatments.

- ECOG 0 or 1

- Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no
archival tumor tissue available

- Adequate organ function

- Life expectancy of 4 months

Key Exclusion Criteria:

- Active central nervous system brain metastases, leptomeningeal disease or primary
tumor of CNS origin

- Active second malignancy (Exceptions: Successfully treated malignancy with no active
disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving
ongoing anticancer hormonal therapy for a previously treated cancer)

- Pre-existing gastrointestinal disorders/conditions interfering with
ingestion/absorption of rucaparib

- Prior treatment with a PARP inhibitor

- More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting

- History of myelodysplastic syndrome or acute myeloid leukemia
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Kim Reiss-Binder, MD

Role: Principal Investigator

Affiliation: University of Pennsylvania

Overall Contact

Name: Clovis Oncology For North America, Latin America and Asia Pacific inquiries:

Phone: 1-415-409-7220, 1-844-258-7662



Facility Status Contact
Innovative Clinical Research Institute
Glendale, California 91204
United States
UCLA Medicine Hematology and Oncology
Los Angeles, California 90024
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Florida Cancer Specialists
Fort Myers, Florida 33901
United States
Florida Cancer Specialists
Saint Petersburg, Florida 33705
United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
United States
University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
New York Cancer And Blood Specialists
Bronx, New York 10469
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York 11776
United States
Ohio State University
Columbus, Ohio 43210
United States
Not yet recruiting
Stephenson Cancer Center - The University of Oklahoma
Oklahoma City, Oklahoma 73104
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
SCRI/Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
The University of Texas Health Center at Tyler
Tyler, Texas 78708
United States
Active, not recruiting
Seattle Cancer Care Alliance/University of Washington
Seattle, Washington 98109
United States