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Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06190899 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celcuity, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06190899 reports 13 study locations spanning 2 distinct geographic areas — top geographies include Other, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06190899?
The interventions under investigation include: Darolutamide (DRUG), Gedatolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06190899?
This trial is sponsored by Celcuity, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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