PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Opna Bio LLC
Study ID
NCT04556617
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • PLX2853 20 mg — DRUG
    PLX2853 tablets
  • Olaparib — DRUG
    Olaparib tablets
  • Abiraterone acetate — DRUG
    Abiraterone acetate tablets
  • Prednisone — DRUG
    Prednisone (or equivalent) tablets
  • PLX2853 40 mg — DRUG
    PLX2853 tablets
  • PLX2853 80 mg — DRUG
    PLX2853 tablets

Study Details

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Key Dates

Start date
Sep 21, 2020
Status verified
Apr 2025
Primary completion
May 24, 2022
Completion
May 24, 2022

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b PLX2853 (20 mg) + Olaparib
    Phase 1b dose escalation
  • Experimental: Phase 1b PLX2853 (40 mg) + Abiraterone Acetate + Prednisone
    Phase 1b dose escalation
  • Experimental: Phase 1b PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
    Phase 1b dose escalation
  • Experimental: Phase 2a PLX2853 (80 mg) + Abiraterone Acetate + Prednisone
    Phase 2a dose expansion
  • Experimental: Phase 1b PLX2853 (40 mg) + Olaparib
    Phase 1b dose escalation

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities [ Time Frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Karmanos Cancer InstituteDetroitMichigan48201-
Columbia University Medical CenterNew YorkNew York10032-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Tennessee Oncology/ Sarah CannonNashvilleTennessee37203-
Virginia Cancer SpecialistFairfaxVirginia22031-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Chicago, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Chicago· Chicago, ILKarmanos Cancer Institute· Detroit, MIColumbia University Medical Center· New York, NYCarolina Urologic Research Center· Myrtle Beach, SCTennessee Oncology/ Sarah Cannon· Nashville, TNVirginia Cancer Specialist· Fairfax, VA

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