Trial · NCT04299113
Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma
NCT04299113, Phase 1, Active not recruiting, Jonsson Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma. Trials, record NCT04299113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04299113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma
- NCT number
- NCT04299113
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
- Rhabdomyosarcoma
- Interventions
- Vinorelbine, Mocetinostat
- First posted
- 2020-03-06
- Last updated
- 2026-07-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To describe any dose-limiting toxicity (DLT) | 1 year | Percentage of subjects with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE (Version 4.03) |
| Primary | To determine the maximum tolerated dose (MTD) or highest protocol defined doses (in the absence of exceeding the MTD) | 1 year | The MTD is the highest dose associated with first-cycle DLT in \< 33% of subjects |
| Secondary | To determine the Recommended Phase 2 Dose (RP2D) for mocetinostat in combination with vinorelbine | 1 year | The RP2D may be determined by the MTD or optimal target inhibition with an acceptable safety profile |
| Secondary | Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 4.03) | 1 year | Assess incidence of all AEs by NCI CTCAE (Version 4.03) grades 1-5 |
| Secondary | Objective Tumor Response | 2 years | Measured using RECIST, Version 1.1 |
| Secondary | Progression Free Survival (PFS) | 2 years | Estimated using Kaplan-Meier methodology |
| Secondary | Disease Control (DC) | 2 years | Proportion of subjects with a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST v1.1 |
| Secondary | Duration of Response (DOR) | 2 years | Measured from the first date a response is identified (either CR or PR) until the date of disease progression |
| Secondary | Area under the Plasma Concentration versus Time Curve (AUC) of mocetinostat | 2 years | Continuous variables will be summarized with means, standard deviations, medians, minimums, and maximums |
| Secondary | Clearance (CL) of mocetinostat | 2 years | Continuous variables will be summarized with means, standard deviations, medians, minimums, and maximums |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Grants0
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.
None in this release.
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/NCT04299113
GET https://conductscience.org/api/trials/v1/NCT04299113/registered