A Study to Evaluate Rucaparib in Patients with Solid Tumors and with Deleterious Mutations in HRR Genes
Clinicaltrials.gov identifier:
NCT04171700
Treatment:
Breast,
Ovarian,
Pancreatic,
Prostate
Study Contact Information:
Principal Investigator:
Kim Reiss-Binder, MD
University of Pennsylvania
A Study to Evaluate Rucaparib in Patients with Solid Tumors and with Deleterious Mutations in HRR Genes (LODESTAR)
About the Study
The LODESTAR study is evaluating the response of the PARP inhibitor rucaparib in people with advanced solid tumors (including breast, ovarian, pancreatic, prostate and other cancers) who have an inherited mutation or an acquired mutation in any of the following genes: BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
Type of Study
This study is a Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors who also have specific genetic mutations.
- Eligible patients will be enrolled in either Cohort A or Cohort B.
- Cohort A: Includes up to 200 patients with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.
- Cohort B: Includes up to 20 patients with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
- Study outcomes will include measures such as overall response rate, length of survival with no disease progression, safety and tolerability of the drug by patients etc.
What the Study Entails
- Oral rucaparib will be administered to study participants twice daily. The starting dose will be 600 mg twice daily.
- The duration of study will be from first dose of study drug until date of progression of disease or an event that would terminate the study for the participant, whichever came first, assessed up to 24 months.
Current Study Sites (more being added)
- California
- Glendale: Innovative Clinical Research Institute
- Los Angeles: UCLA Medicine Hematology and Oncology - Not yet recruiting
- Florida
- Fort Myers: Florida Cancer Specialists
- Saint Petersburg: Florida Cancer Specialists
- Iowa
- Iowa City: University of Iowa Hospital and Clinics
- Massachusetts
- Boston: Dana-Farber Cancer Institute
- New York
- Bronx: New York Cancer and Blood Specialists
- New York: Columbia University Irving Medical Center
- Port Jefferson Station: New York Cancer and Blood Specialists
- Pennsylvania
- Philadelphia: University of Pennsylvania
- Tennessee
- Chattanooga: SCRI/Tennessee Oncology
- Nashville: Tennessee Oncology
Principal Investigator
Kim Reiss-Binder, MD, University of Pennsylvania
Patients, 18 years and older, who meet the following criteria:
- Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
- Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: See exclusion criteria list below for exceptions.
- At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease.
- Tumor tissue available for analysis, or must be willing to have a biopsy if no archived tumor tissue available
- Life expectancy of 4 months
- Active central nervous system brain metastases, leptomeningeal disease (affecting the lining of the brain and spinal cord) or primary tumor of central nervous system (CNS) origin
- Active second malignancy
- Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
- Prior treatment with a PARP inhibitor
- 3 or more prior lines of chemotherapy in the locally advanced/metastatic setting
- History of myelodysplastic syndrome (body is not making enough healthy blood cells) or acute myeloid leukemia
- Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutation
- Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer with a BRCA1 or BRCA2 mutation
- Patients with metastatic castration-resistant prostate cancer with a BRCA1 or BRCA2 mutation