Trial · NCT05627245
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (Dose escalation) | Up to end of cycle 1 (Cycles = 21 days) | Defined as the highest dose level at which \< 33% of the dose cohort (0 of 3 or 1 of 6) experience a dose-limiting toxicity in the first cycle. |
| Secondary | Disease response | Following cycle 2 and 6, and every 3-6 cycles, assessed up to 1 year after completion of study treatment | Will be assessed by positron emission tomography/computed tomography scan following cycle 2 and 6, and then every 3-6 cycles. Response will be defined by the Lugano Classification. |
| Secondary | Overall response rate | Up to 1 year after completion of study treatment | Defined as complete response + partial response. Will be estimated and the exact 95% confidence interval will be constructed based on binomial distribution. |
| Secondary | Progression-free survival | From time to enrollment to progression or death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method and compared by the log-rank test. |
| Secondary | Overall survival | From time to enrollment to death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method and compared by the log-rank test. |
| Secondary | Duration of response | From first response to relapse or death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method. |
| Secondary | Total number of cycles | Up to 2 years | The mean and range will be calculated. |
| Secondary | Number of dose delays | Up to 2 years | The mean and range will be calculated. |
| Secondary | Number of dose reductions | Up to 2 years | The mean and range will be calculated. |
| Secondary | Pharmacokinetic profile for tazemetostat and belinostat | Cycle 1, day 1 (C1D1) (belinostat only) and C2D1 | Plasma concentrations of both tazemetostat and belinostat using area under the "concentration time" curve, maximum concentration, time to maximum concentration, and half-life will be calculated for the two study drugs. |
| Secondary | Incidence of adverse events | Up to 4 weeks after completion of study treatment | National Cancer Institute toxicity Grade 3 and Grade 4 laboratory abnormalities will be listed. Summary statistics will be provided for all laboratory values. |
| Other | Modulation in immune function | During cycle 1 (Cycles = 21 days) | Will be presented in descriptive terms. |
| Other | Histone acetylation and methylation | Up to 2 years | Will be assessed separately for the wild type and the mutant groups and will be compared using a two-sample Wilcoxon rank-sum test. |
| Other | Gene signature biomarker for response | Up to 2 years | Will be evaluated next generation sequencing and presented in descriptive terms. Gene signature biomarker data analysis will be completed using Lasso-based elastic net method. |
| Other | Modulation of histone acetylation and methylation | Up to 2 years | Will be presented in descriptive terms. |
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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