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Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 2025 to Jan 2028 Completion date: Nov 2027 to Jan 2030v4 Show 1 more changeShow less
    • Completion date: Nov 2027 to Jan 2030
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 14 to 13 · Start date changed from estimate of Jan 2024 to Jan 1, 2024v2 Show 2 more changesShow less
    • Study sites: 14 to 13
    • Start date changed from estimate of Jan 2024 to Jan 1, 2024
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.
Trial Details
NCT Number NCT06190899
Lead Sponsor Celcuity Inc
Conditions mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease, Prostatic Neoplasms, Castration-Resistant, Prostate Cancer
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov