Trial · NCT03925428
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose | At 28 days | Assesses with dose limiting toxicities. Descriptive statistics, including means, standard deviations, and ranges for continuous parameters, as well as percentages and frequencies for categorical parameters, will be presented. |
| Secondary | Incidence of adverse events | Up to 2 years | Graded per Common Terminology Criteria for Adverse Events version 5.0. National Cancer Institute toxicity grade 3 and grade 4 laboratory abnormalities will be listed. |
| Secondary | Overall response rate (ORR) | Up to 2 years | The exact two-sided 95% confidence intervals (CIs) for the RR will be reported. |
| Secondary | Progression-free survival | Up to 2 years | Will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on Greenwood's variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. |
| Secondary | Overall survival | Up to 2 years | Will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on Greenwood's variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. |
| Secondary | Duration of response | Up to 2 years | The 95% CIs for the duration of response will be reported. |
| Other | Effect of GSK525762C and entinostat combination therapy on apoptosis rate | Up to 2 years | Measured by an apoptosis multiplex immunoassay. Statistical and bioinformatic data analysis for laboratory non-omics data and clinical data will utilize the following general strategies, as appropriate. For single time-point lab data, tests of hypotheses concerning within-group comparisons will be completed using the paired t-test or Wilcoxon signed-rank test for continuous parameters of interest, or McNemar's Chi-square test for categorical parameters of interest. Between-group comparisons will be assessed using either analysis of variance (ANOVA) with adjusted least squares means or Fisher's exact test, for continuous or categorical variables of interest, respectively. For count or binary multiple time-points or correlated data, tests of between-group comparisons will be completed using the generalized estimating equation (GEE) statistical procedure for longitudinal data analysis with multiple observable vectors for the same subject. |
| Other | Effect of GSK525762C and entinostat combination therapy on c-MYC expression | Up to 2 years | Measured by ribonucleic acid (RNA) and protein expression. Statistical and bioinformatic data analysis for laboratory non-omics data and clinical data will utilize the following general strategies, as appropriate. For single time-point lab data, tests of hypotheses concerning within-group comparisons will be completed using the paired t-test or Wilcoxon signed-rank test for continuous parameters of interest, or McNemar's Chi-square test for categorical parameters of interest. Between-group comparisons will be assessed using either ANOVA with adjusted least squares means or Fisher's exact test, for continuous or categorical variables of interest, respectively. For count or binary multiple time-points or correlated data, tests of between-group comparisons will be completed using the GEE statistical procedure for longitudinal data analysis with multiple observable vectors for the same subject. |
| Other | Effect of GSK525762C and entinostat combination therapy on YAP1 expression | Up to 2 years | Measured by RNA and protein expression. Statistical and bioinformatic data analysis for laboratory non-omics data and clinical data will utilize the following general strategies, as appropriate. For single time-point lab data, tests of hypotheses concerning within-group comparisons will be completed using the paired t-test or Wilcoxon signed-rank test for continuous parameters of interest, or McNemar's Chi-square test for categorical parameters of interest. Between-group comparisons will be assessed using either ANOVA with adjusted least squares means or Fisher's exact test, for continuous or categorical variables of interest, respectively. For count or binary multiple time-points or correlated data, tests of between-group comparisons will be completed using the GEE statistical procedure for longitudinal data analysis with multiple observable vectors for the same subject. |
| Other | Effect of GSK525762C and entinostat combination therapy on tumor burden | Up to 2 years | As measured by whole exome sequencing and RNA sequencing (RNASeq) on circulating tumor deoxyribonucleic acid (DNA) specimens. |
| Other | Effect of GSK525762C and entinostat combination therapy on gene expression patterns | Up to 2 years | As measured by whole exome sequencing and RNASeq on circulating tumor DNA specimens. |
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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