Trial · NCT05019716
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
NCT05019716, Phase 1, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma. Trials, record NCT05019716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05019716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
- NCT number
- NCT05019716
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Advanced NUT Carcinoma, Metastatic NUT Carcinoma, Unresectable NUT Carcinoma
- Interventions
- BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, Biospecimen Collection, Carboplatin, Cisplatin, Etoposide, Imaging Procedure, Paclitaxel
- First posted
- 2021-08-25
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) (phase 1) | Up to 21 days of each cycle | MTD is the highest dose level at which \< 33% of the cohort experience a dose limiting toxicity in the first cycle. |
| Secondary | Objective response rate (phase 1 and non-thoracic, non-BRD4 exploratory cohort) | Up to 2 years | Examined using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Point estimates and exact binomial 90% confidence intervals are provided. |
| Secondary | Duration of response (phase 1 and non-thoracic, non-BRD4 exploratory cohort) | From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years | Examined using the RECIST version 1.1 criteria. Kaplan and Meier method is used to estimate overall survival in all patients. |
| Secondary | Progression-free survival (phase 1 and non-thoracic, non-BRD4 exploratory cohort) | From initiation of study treatment until the identification of disease progression or death, assessed up to 2 years | Examined using the RECIST version 1.1 criteria. |
| Secondary | Overall survival (phase 1 and non-thoracic, non-BRD4 exploratory cohort) | From start of study treatment until death from any cause, assessed up to 2 years | Examined using the RECIST version 1.1 criteria. Kaplan and Meier method is used to estimate overall survival in all patients. |
| Secondary | Pharmacodynamic parameters (carboplatin/paclitaxel safety cohort and non-thoracic, non-BRD4 exploratory cohort) | Assessed on-treatment or at time-of-progression, up to 2 years | Pharmacodynamic parameters assessed on-treatment or at time-of-progression will be compared to those in pre-treatment biopsies using paired statistics such as the Wilcoxon signed-rank test. All biomarker data analysis will provide descriptive statistics with 95% confidence interval and will assess changes over time using the Wilcoxon Sign-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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38501690 | DERIVED |
Source PubMed
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/NCT05019716
GET https://conductscience.org/api/trials/v1/NCT05019716/registered