Trial · NCT07190300
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I (Group A and Group B): Dose-limiting toxicities (DLTs) | From the first dose of study treatment through the end of Cycle 1, up to 28 days | A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value that was not clearly attributable to the underlying disease or an extraneous cause, occurred during the first 28 days of treatment with tulmimetostat, and met the protocol-defined dose-limiting toxicity criteria. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Dose-limiting toxicities were included in the Bayesian Logistic Regression Model used to support dose-escalation decisions. |
| Primary | Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The incidence, type, frequency, seriousness, and severity of adverse events and serious adverse events will be summarized. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. |
| Primary | Phase I (Group A and Group B): Number of Participants with dose adjustments | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The number of participants with dose reductions, dose interruptions, or permanent discontinuations, including the reasons for the dose adjustments, will be summarized by treatment group and dose cohort. |
| Primary | Phase I (Group A and Group B): Dose Intensity | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | Dose intensity, calculated as the actual cumulative dose received divided by the actual duration of exposure, and relative dose intensity, calculated as the dose intensity divided by the planned dose intensity, will be summarized using descriptive statistics for each study drug. |
| Primary | Phase I (Group A and Group B): Duration of exposure to each study drug | From the first dose of study treatment through the 30-day safety follow-up, assessed up to approximately 79 months | The duration of exposure, in months, to each study drug will be summarized using descriptive statistics by treatment group and dose cohort. |
| Primary | Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL at Month 6 | At Month 6, with confirmation by a second prostate-specific antigen assessment performed at least 3 weeks later | Prostate-Specific Antigen (PSA) response rate is defined as the proportion of participants who achieved a prostate-specific antigen level below 0.2 ng/mL at Month 6, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later. |
| Secondary | Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | Plasma concentrations of tulmimetostat and darolutamide will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group A. |
| Secondary | Phase I (Group A): AUC of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | The area under the concentration-time curve from time zero to the last quantifiable concentration, the area under the concentration-time curve from time zero extrapolated to infinity, and the area under the concentration-time curve over a dosing interval at steady state will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase I (Group A): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Darolutamide | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Cycle 1, Day 2: 0 and 24 hours post-dose for tulmimetostat; Cycle 1, Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days | The maximum observed plasma concentration of tulmimetostat and darolutamide will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days. | Plasma concentrations of tulmimetostat and abiraterone will be evaluated using pharmacokinetic samples collected from participants across the evaluated dose levels in Phase I, Group B. |
| Secondary | Phase I (Group B): AUC of Tulmimetostat and Abiraterone | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days. | The area under the concentration-time curve from time zero to the last quantifiable concentration, the area under the concentration-time curve from time zero extrapolated to infinity, and the area under the concentration-time curve over a dosing interval at steady state will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase I (Group B): Maximum Observed Plasma Concentration (Cmax) of Tulmimetostat and Abiraterone | Cycles 1 and 2, Day 1: 0, 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose; Day 2: 0 and 24 hours post-dose; Days 8 and 15: 0 and 2 hours post-dose; Cycles 3 to 5, Day 1: pre-dose. Each cycle is 28 days. | The maximum observed plasma concentration of tulmimetostat and abiraterone will be derived, as applicable, and summarized using descriptive statistics. |
| Secondary | Phase II (Group A): Radiographic progression free survival (rPFS) | From randomization until the first documented radiographic disease progression or death from any cause, whichever occurs first, assessed up to approximately 79 months | Radiographic progression free survival (rPFS) is defined as the time from randomization to the first documented disease progression according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator, or death from any cause, whichever occurred first. |
| Secondary | Phase II (Group A):Overall survival (OS) | From randomization until death from any cause, assessed up to approximately 79 months | Overall survival (OS) is defined as the time from randomization to death from any cause. |
| Secondary | Phase II (Group A): Objective Response Rate (ORR) | From randomization until disease progression, death, or the last adequate tumor assessment, assessed up to approximately 79 months | Objective response (OR) is defined as the proportion of participants with a best overall response of confirmed complete response or partial response according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator. |
| Secondary | Phase II (Group A): Best Overall Response (BOR) | From randomization until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months | Best Overall response (BOR) is defined as the best response recorded from the start of study treatment until disease progression or recurrence according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator. |
| Secondary | Phase II (Group A): Duration of Response (DOR) | From the first documented complete or partial response until disease progression or death from any cause, whichever occurred first, assessed up to approximately 79 months | Duration of response (DOR) is defined, for participants with a confirmed complete or partial response, as the time from the first documented response until the first documented disease progression according to Prostate Cancer Working Group 3-modified Response Evaluation Criteria in Solid Tumors, version 1.1, as assessed by the investigator, or death from any cause. |
| Secondary | Phase II (Group A): Prostate-Specific Antigen 50 (PSA50) response rate | From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months | Prostate-Specific Antigen 50 (PSA50) response is defined as a reduction of at least 50% from baseline in prostate-specific antigen at any post-baseline time point, confirmed by a second prostate-specific antigen assessment performed at least 3 weeks later. |
| Secondary | Phase II (Group A): Prostate-Specific Antigen (PSA) Response below 0.1 ng/mL | From randomization until the last prostate-specific antigen assessment, assessed up to approximately 79 months | Prostate-Specific Antigen (PSA) Response below 0.1 ng/mL is defined as achievement of a prostate-specific antigen level below 0.1 ng/mL at any post-baseline time point. |
| Secondary | Phase II (Group A): Time to castration-resistant prostate cancer (CRPC) | From randomization until prostate-specific antigen progression, radiographic progression in bone, or radiographic progression in soft-tissue or visceral lesions, whichever occurred first, assessed up to approximately 79 months | Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of prostate-specific antigen progression, radiographic progression based on bone lesions, or radiographic progression based on soft-tissue or visceral lesions. |
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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