Study Stopped
The study was terminated due to a change in development priorities.
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
LODESTAR
A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
1 other identifier
interventional
83
1 country
19
Brief Summary
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
January 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedResults Posted
Study results publicly available
October 2, 2023
CompletedOctober 2, 2023
September 1, 2023
2.4 years
November 19, 2019
May 31, 2023
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response Rate by Investigator
Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
From first dose of study drug until disease progression (up to approximately 2 years)
Secondary Outcomes (7)
Overall Response Rate by Independent Radiology Review
From first dose of study drug until disease progression (up to approximately 2 years)
Duration of Response
From first dose of study drug until disease progression (up to approximately 2 years)
Disease Control Rate
From first dose of study drug until disease progression (up to approximately 2 years)
Progression-free Survival
From first dose of study drug until disease progression (up to approximately 2 years)
Overall Survival
From first dose of study drug until disease progression (up to approximately 2 years)
- +2 more secondary outcomes
Study Arms (1)
Rucaparib
EXPERIMENTALEligible 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.
Interventions
Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
Study Sites (19)
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
St. 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
Beth Israel Deaconess Medical Cancer Surgical Pavilion
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, 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
New York Cancer And Blood Specialists
The Bronx, New York, 10469, United States
Ohio State University
Columbus, Ohio, 43210, United States
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
Seattle Cancer Care Alliance/University of Washington
Seattle, Washington, 98109, United States
Related Publications (1)
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.
PMID: 40632975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kim Reiss Binder
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Reiss-Binder, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2019
First Posted
November 21, 2019
Study Start
January 16, 2020
Primary Completion
June 8, 2022
Study Completion
July 15, 2022
Last Updated
October 2, 2023
Results First Posted
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
- Access Criteria
- Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by Clovis Oncology.