A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Brown University
Study ID
NCT04253262
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    Rucaparib (PO twice daily continuous)
  • Copanlisib — DRUG
    Copanlisib (IV day 1, 8, 15; 28 day cycle)

Study Details

This is a single arm Phase Ib/II, open label, safety, pharmacokinetic and efficacy clinical study in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with the combination of copanlisib and rucaparib for as long as the patient does not have clinically significant progressive disease and/or unacceptable toxicity and/or as long as the investigator deems that the patient is benefiting from treatment. Treatment may also be stopped if the patient withdraws consent, or study termination occurs.

Key Dates

Start date
Apr 3, 2020
Status verified
May 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level -2
    300 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib
  • Experimental: Dose Level -1
    400 mg Rucaparib, 45 mg (day 1 \& 15) Copanlisib
  • Experimental: Dose Level 1
    400 mg Rucaparib, 45 mg Copanlisib
  • Experimental: Dose Level 2
    500 mg Rucaparib, 45 mg Copanlisib
  • Experimental: Dose Level 3
    600 mg Rucaparib, 45 mg Copanlisib
  • Experimental: Dose Level 4
    600 mg Rucaparib, 60 mg Copanlisib

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Helen Diller Family Comprehensive Cancer Center University of California San FranciscoSan FranciscoCalifornia94115-
Lifespan Cancer InstituteProvidenceRhode Island02903-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Helen Diller Family Comprehensive Cancer Center University of California San Francisco· San Francisco, CALifespan Cancer Institute· Providence, RI

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