Trial · NCT04116359
Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma
NCT04116359, Phase 1, Phase 2, Withdrawn, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma. Trials, record NCT04116359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04116359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma
- NCT number
- NCT04116359
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic NUT Carcinoma, Unresectable NUT Carcinoma
- Interventions
- Cisplatin, Etoposide, Etoposide Phosphate, Molibresib, Molibresib Besylate
- First posted
- 2019-10-04
- Last updated
- 2020-09-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (Phase I) | Up to 21 days | Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (V.) 5.0 criteria. |
| Primary | Maximum tolerated dose (MTD) (Phase I) | Up to 21 days | The MTD will be the highest dose level at which 0/3 or 1/6 subjects experience a dose limiting toxicity (DLT). Data will be summarized using descriptive statistics for continuous variables and frequencies, percentages for discrete variables, and presented by dose group, as appropriate. |
| Primary | Overall response rate (ORR) (Phase II) | Up to 2 years | Radiological response will be assessed by RECIST 1.1 criteria and will be graded as CR, PR, SD and PD. Point estimates and exact binomial 90% confidence intervals will be provided. |
| Secondary | Overall response rate (ORR) (Phase I, Phase II, and Non-BRD4 Exploratory Cohort) | Up to 2 years | Radiological response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be graded as complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Point estimates and exact binomial 90% confidence intervals will be provided. |
| Secondary | Duration of response (DoR) rates (Phase I, Phase II, and Non-BRD4 Exploratory Cohort) | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years | The method of Kaplan and Meier will be used to estimate duration of response in those that achieve PR or CR. |
| Secondary | Progression free survival (Phase I, Phase II, and Non-BRD4 Exploratory Cohort) | From study enrollment until the identification of disease progression or death, assessed up to 2 years | |
| Secondary | Overall survival (OS) rates (Phase I, Phase II, and Non-BRD4 Exploratory Cohort) | Up to 2 years | The method of Kaplan and Meier will be used to estimate overall survival in all patients. |
| Secondary | Pharmacodynamic parameters (Phase I, Phase II, and Non-Thoracic, Non-BRD4 Exploratory Cohort) | Up to 2 years | Will be compared to those in pre-treatment biopsies using paired statistics such as the Wilcoxon signed-rank test. |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|---|---|---|---|
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | 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/NCT04116359
GET https://conductscience.org/api/trials/v1/NCT04116359/registered