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NCT06190899 · ClinicalTrials.gov registry record · Phase 1
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study of Prostate Cancer and Prostatic Neoplasms, Castration-Resistant, sponsored by Celcuity.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 13
- Study locations
NCT06190899 is a Phase 1 study of Prostate Cancer and Prostatic Neoplasms, Castration-Resistant that is actively recruiting participants, run by Celcuity. The registered enrollment target is 54 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (91% lower). The trial reports 13 study locations across 2 states.
The verdict
NCT06190899, a Phase 1 study of Prostate Cancer and Prostatic Neoplasms, Castration-Resistant, is actively recruiting participants, sponsored by Celcuity.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Gedatolisib
Study Locations (13)
Other
- Centre Jean Perrin - Clermont-Ferrand
- Institut Paoli-Calmettes - Marseille
- Centre Antoine Lacassagne - Nice
- Institut Gustave Roussy - Villejuif
- Hospital Clinic Barcelona - Barcelona
- Institut Catala d'Oncologia - Barcelona
- Hospital General Universitario Gregorio Maranon - Madrid
- Hospital 12 de Octubre - Madrid
- Instituto Valenciano de Oncología - Valencia
- Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita - Cambridge
- University Hospital Southampton NHS Foundation Trust - Southampton General Hospital - Southampton
- Royal Marsden NHS Foundation Trust - Sutton
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06190899
The ClinicalTrials.gov registry entry for NCT06190899 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Celcuity, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Darolutamide is the first listed.
NCT06190899 reports 13 study locations spanning 2 distinct geographic areas - top geographies include Other, Michigan.
Frequently Asked Questions
What is clinical trial NCT06190899 about?
NCT06190899 is a clinical study titled "Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer". 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.
What is the current status of trial NCT06190899?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2024-01-01. Estimated completion is 2027-11.
What conditions does trial NCT06190899 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostatic Neoplasms, Castration-Resistant, mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male.
What interventions are being tested in trial NCT06190899?
The interventions under investigation include: Darolutamide (DRUG), Gedatolisib (DRUG).
Who is sponsoring clinical trial NCT06190899?
This trial is sponsored by Celcuity, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06190899 being conducted?
This trial has 13 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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