Trial · NCT04299113
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| Secondary | Half-Life [T1/2] of mocetinostat | 2 years | Continuous variables will be summarized with means, standard deviations, medians, minimums, and maximums |
| Secondary | Volume of Distribution (Vd) of mocetinostat | 2 years | Continuous variables will be summarized with means, standard deviations, medians, minimums, and maximums |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04299113/registered