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Brief Title: A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes

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

INTRODUCTION

  • Org Study ID: CO-338-100
  • Secondary ID: N/A
  • NTC ID: NCT04171700
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

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

CONDITION

  • Solid Tumor

ELIGIBILITY


Key Inclusion Criteria:

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

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

- 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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Kim Reiss-Binder, MD

Role: Principal Investigator

Affiliation: University of Pennsylvania

Overall Contact

Name: Kim Reiss-Binder, MD

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

Email: medinfo@clovisoncology.com

LOCATION

Facility Status Contact
Facility: UCLA Medicine Hematology and Oncology
Los Angeles, California 90024
United States
Status: Recruiting Contact: N/A
Facility: UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Status: Recruiting Contact: N/A
Facility: Florida Cancer Specialists
Fort Myers, Florida 33901
United States
Status: Recruiting Contact: N/A
Facility: Florida Cancer Specialists
Saint Petersburg, Florida 33705
United States
Status: Recruiting Contact: N/A
Facility: H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United States
Status: Recruiting Contact: N/A
Facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: N/A
Facility: Beth Israel Deaconess Medical Cancer Surgical Pavilion
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: N/A
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: N/A
Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: N/A
Facility: New York Cancer And Blood Specialists
Bronx, New York 10469
United States
Status: Recruiting Contact: N/A
Facility: Columbia University Irving Medical Center
New York, New York 10032
United States
Status: Recruiting Contact: N/A
Facility: New York Cancer and Blood Specialists
Port Jefferson Station, New York 11776
United States
Status: Recruiting Contact: N/A
Facility: Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: N/A
Facility: Stephenson Cancer Center - The University of Oklahoma
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: N/A
Facility: University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: N/A
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: N/A
Facility: SCRI/Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404
United States
Status: Recruiting Contact: N/A
Facility: Tennessee Oncology
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: Seattle Cancer Care Alliance/University of Washington
Seattle, Washington 98109
United States
Status: Recruiting Contact: N/A