Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05501548
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib 300mg by mouth twice daily
  • Vitamin C — DIETARY_SUPPLEMENT
    Ascorbic acid 1g/kg administered intravenously twice weekly

Study Details

This is a 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.

Key Dates

Start date
Jun 30, 2023
Status verified
Jan 2025
Primary completion
Oct 14, 2024
Completion
Oct 14, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib and Vitamin C
    Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons.

Primary Outcome Measure

PSA50 Response [ Time Frame: up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-

Find similar trials in Washington D.C., DC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Sibley Memorial Hospital· Washington D.C., DCSidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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