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Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Enrollment reduced: 39 → 20 participants
    • Secondary endpoints: 4 to 1
    • Study description expanded, about 28 words
    v9
  2. Start date: Jan 30, 2026 to Jun 2026
    • Primary completion date: Jan 30, 2028 to Jun 2028
    • Study completion date: Jan 30, 2030 to Jun 2030
    v8
  3. Start date: Oct 30, 2025 to Jan 30, 2026
    • Primary completion date: Oct 30, 2027 to Jan 30, 2028
    • Study completion date: Oct 30, 2029 to Jan 30, 2030
    v7
  4. Start date: Jul 30, 2025 to Oct 30, 2025
    • Primary completion date: Jul 30, 2027 to Oct 30, 2027
    • Study completion date: Jul 30, 2029 to Oct 30, 2029
    v6
  5. Start date: Apr 30, 2025 to Jul 30, 2025
    • Primary completion date: Apr 30, 2027 to Jul 30, 2027
    • Study completion date: Apr 30, 2029 to Jul 30, 2029
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Mar 1, 2025 to Apr 30, 2025
    • Study sites: 1 to 3
    • Primary completion date: Mar 1, 2027 to Apr 30, 2027
    • Study completion date: Mar 1, 2029 to Apr 30, 2029
  2. Start date: Dec 1, 2024 to Mar 1, 2025
    • Primary completion date: Dec 1, 2026 to Mar 1, 2027
    • Study completion date: Dec 1, 2028 to Mar 1, 2029
    v3
  3. Start date: Oct 1, 2024 to Dec 1, 2024
    • Primary completion date: Oct 1, 2026 to Dec 1, 2026
    • Study completion date: Oct 1, 2028 to Dec 1, 2028
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.
Trial Details
NCT Number NCT06616155
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Incyte Corporation
Conditions
(from sponsor)		 Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov