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Phase 2 Trial of Olaparib in Patients with Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations (HCRN GU15-262)
Protocol Number:
Phase II
Jean Hoffman-Censits
Johns Hopkins Kimmel Cancer Center in Baltimore
This is a single arm open label Phase II trial of olaparib therapy in subjects with metastatic urothelial cancer with the DDR alterations with the primary purpose to estimate the objective response rate from treatment with olaparib.
Good performance status. If the patient has brain mets, it has been treated and is stable. Adequate organ function. The patient must comply with study procedures for the entire length of the study. Must have adequate archival tissue available. Stable cardiac history. Must be able to swallow tablets.
Patients will take Olaparib by mouth twice a day for each 28 day cycle. The dose should be taken at approximately the same time each day approximately 12 hours apart. The tablets should be swallowed whole without chewing, crushing or dissolving them. Olaparib can be taken with or without food. Patients should avoid grapefruit juice as well as Seville oranges while on therapy. CT scans will be done every 8 weeks to evaluate their disease status.
Last Update
08/08/2020 05:02 AM