Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
Summary
This is a multi-center phase II study to evaluate the safety and clinical activity of the
combination of olaparib and high-dose IV ascorbate, as second or later line of therapy, in
castration resistant prostate cancer patients with no known DNA repair gene mutations (DDRm).
In brief, the primary endpoint is PSA50 response , defined by a 50% reduction in PSA from
baseline . The secondary endpoints are assessing the PSA doubling time, radiographic and PSA
PFS, safety and tolerability as defined by the incidence of grade 3 to 5 toxicities, and
measuring overall survival.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
AstraZeneca McGuff Pharmaceuticals, Inc. The Marcus Foundation