Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Kidney Cancer
- Kidney Cancer Metastatic
- Metastatic Renal Cell Carcinoma
- Renal Carcinoma
- Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 120 years
- Gender
- Both males and females
Description
The trial will enroll up to 20 participants. Following enrollment, participants will be initially treated with olaparib 150mg by mouth twice daily for one month. After one month of therapy, the dose of olaparib will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater ...
The trial will enroll up to 20 participants. Following enrollment, participants will be initially treated with olaparib 150mg by mouth twice daily for one month. After one month of therapy, the dose of olaparib will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater adverse events experienced. All participants will be reassessed at least monthly for toxicity, including laboratory investigations. Radiological scans will be performed approximately every 3 months to assess for disease response. Treatment will be continued until clinical and/or radiographic progression according to RECIST 1.1 criteria or unmanageable toxicity requiring cessation.
Tracking Information
- NCT #
- NCT03786796
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Mark C Markowski, MD, Ph.D Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins