Trial · NCT06190899
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06190899, Phase 1, Phase 2, Recruiting, Celcuity Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT06190899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06190899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT06190899
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, estimated
- 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
- Interventions
- Gedatolisib, Darolutamide
- First posted
- 2024-01-05
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) | Cycle 1, Day 1 to end of safety follow up (each cycle is 28 days and safety follow up will continue until 30 days after last dose of study medication) | 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 |
| Primary | Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC | Through Phase I completion, an average of 1 year. | Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0 |
| Primary | Phase 2: Assessment of the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm | 6 months | Radiographic progression-free survival rate at 6 months as measured by the Kaplan-Meier (K-M) method and assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria |
| Secondary | Assessment of the preliminary efficacy of gedatolisib in combination with darolutamide by arm | 9 and 12 months post Cycle 1 Day 1 (each cycle is 28 days); 18 and 24 months post Cycle 1 Day 1 (each cycle is 28 days) | Radiographic progression-free survival rates at 9 and 12 months and overall rPFS Overall Survival (OS) rate at 18 and 24 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06190899
GET https://conductscience.org/api/trials/v1/NCT06190899/registered