A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
NCT ID: NCT04171700
Last Updated: 2023-10-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
83 participants
INTERVENTIONAL
2020-01-16
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rucaparib
Eligible participants will be enrolled in either Cohort A or Cohort B.
Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.
Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
Rucaparib
Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
Interventions
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Rucaparib
Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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pharmaand GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Reiss-Binder, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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UCLA Medicine Hematology and Oncology
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Beth Israel Deaconess Medical Cancer Surgical Pavilion
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
New York Cancer And Blood Specialists
The Bronx, New York, United States
Ohio State University
Columbus, Ohio, United States
Stephenson Cancer Center - The University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI/Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Seattle Cancer Care Alliance/University of Washington
Seattle, Washington, United States
Countries
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References
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Anbil S, Seewald NJ, Chiorean EG, Hussein M, Kasi PM, Laux DE, Schwartz GK, Shapiro GI, Lin KK, Craib M, Maloney L, McLachlan K, Tukachinsky H, Schrock AB, Wang S, Sokol ES, Decker B, Nathanson KL, Domchek SM, Reiss KA. LODESTAR: A Single-Arm Phase II Study of Rucaparib in Solid Tumors With Pathogenic Germline or Somatic Variants in Homologous Recombination Repair Genes. JCO Precis Oncol. 2025 Jul;9:e2500090. doi: 10.1200/PO-25-00090. Epub 2025 Jul 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CO-338-100
Identifier Type: -
Identifier Source: org_study_id
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