Trial · NCT06785636
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide | 28 days | Occurrence and severity of Serious Adverse Events (SAEs) and clinically relevant Adverse Events (AEs), and clinically significant changes in safety laboratory values and electrocardiograms (ECGs) |
| Primary | Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide | 28 days | Frequency and type of DLTs used to determine the maximum tolerated dose (MTD) and RP2Ds |
| Primary | Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamide | Through duration of treatment, estimated 6 months | 1. Occurrence and severity of SAEs, clinically relevant AEs, and clinically significant changes in safety laboratory values, physical examination (PE) findings, vital signs, and ECGs. 2. Safety and selection of pocenbrodib RP2D for combination with darolutamide for subsequent development |
| Primary | Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamide | Through duration of treatment, estimated 6 months. | Post-177Lu-PSMA-617 (Post-PLUVICTO®) pre-taxane mCRPC: Radiographic progression-free survival (rPFS), assessed as time from randomization to first occurrence of Radiographic progression-free survival (rPFS) according to; i) Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and ii) Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever comes first. |
| Secondary | Phase 1b: Plasma PK Cmax | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Cmax |
| Secondary | Phase 1b: Plasma PK Tmax | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Tmax, |
| Secondary | Phase 1b: Plasma PK AUC for pocenbrodib | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first. | Plasma PK AUC parameter for pocenbrodib. Pocenbrodib parameters compared to monotherapy Arms 1/2. |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of adverse events (AEs) | Through duration of treatment, estimated 6 months. | |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of serious adverse events (SAEs) | Through duration of treatment, estimated 6 months. | |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of adverse events of special interest (AESIs) | Through duration of treatment, estimated 6 months. | |
| Secondary | Phase 2a: Characterize the PK of pocenbrodib in combination with darolutamide | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Characterize the PK of pocenbrodib in combination with darolutamide in participants with mCRPC after progressing after 177Lu-PSMA-617 (PLUVICTO®) treatment |
| Secondary | Phase 2a: Plasma PK Cmax pocenbrodib/darolutamide | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Cmax for pocenbrodib and darolutamide combined |
| Secondary | Phase 2a: Plasma PK Tmax pocenbrodib/darolutamide | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Tmax for pocenbrodib and darolutamide combined |
| Secondary | Phase 2a: Plasma PK AUC0-24 pocenbrodib/darolutamide | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for AUC0-24 for pocenbrodib and darolutamide combined |
| Secondary | Phase 2a: rPFS (radiographic Progression Free Survival) | Through duration of treatment, estimated 6 months | Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for rPFS (radiographic Progression Free Survival) |
| Secondary | Phase 2a: Prostate Specific Antigen (PSA) 50% (PSA50) change from baseline. | Through duration of treatment, estimated 6 months | Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for Prostate Specific Antigen (PSA) 50% (PSA50) change from baseline |
| Secondary | Phase 2a: Prostate Specific Antigen PSA 90% (PSA90) change from baseline. | Through duration of treatment, estimated 6 months | Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for Prostate Specific Antigen PSA 90% (PSA90) change from baseline |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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