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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: Recruiting Phase 1 study of Prostate Cancer and Prostatic Neoplasms, Castration-Resistant, sponsored by Celcuity.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Type, incidence, severity (as graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities
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 |
What NCT06190899 shows while recruiting
NCT06190899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (91% lower).
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 lists 13 locations in 2 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06190899's enrollment target sits among peer trials
54 460th of 735 higher than 274 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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