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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Jan 2024 to Jan 2027
    • Study completion date: May 2024 to Jan 2027
    v9
  3. Primary completion date: Nov 2023 to Jan 2024v8
  4. Primary completion date: Jul 2023 to Nov 2023
    • Study completion date: Jan 2024 to May 2024
    v7
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 44 to confirmed 13
    • Site details revised at 2 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jul 14, 2021 to Jul 2023v5
  2. Study sites: 1 to 2
    • Primary completion date changed from estimate of Jan 2021 to Jul 14, 2021
    v4
  3. Eligibility criteria expanded, about 191 wordsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2020 to Apr 3, 2020
    • Site details revised
    • Study title shortened, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04253262
Lead Sponsor Brown University
Collaborators: Rhode Island Hospital, The Miriam Hospital, Bayer, Clovis Oncology, Inc.
Conditions
(from sponsor)		 Metastatic Castration-resistant Prostate Cancer
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov