Trial · NCT03925428
Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
NCT03925428, Phase 1, Withdrawn, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas. Trials, record NCT03925428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03925428
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
- NCT number
- NCT03925428
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III T-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage IV T-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Pancreatic Carcinoma, Refractory T-Cell Non-Hodgkin Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
- Interventions
- Entinostat, Molibresib
- First posted
- 2019-04-24
- Last updated
- 2020-09-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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/NCT03925428
GET https://conductscience.org/api/trials/v1/NCT03925428/registered