Trial · NCT04065399
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose-limiting toxicities (DLTs) (Phase 1) | Approximately 1 year | Assessed by the NCI CTCAE version 5.0 (Phase 1) |
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) (Phase 1) | Approximately 1 year | Assessed by the NCI CTCAE version 5.0 (Phase 1) |
| Primary | Cmax (Phase 1) | Approximately 1 year | Maximum plasma concentration (Cmax) of revumenib and relevant metabolites (Phase 1) |
| Primary | Tmax (Phase 1) | Approximately 1 year | Time to observed maximum plasma concentration of revumenib and relevant metabolites (Phase 1) |
| Primary | AUC0-t (Phase 1) | Approximately 1 year | Area under the plasma concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of revumenib and relevant metabolites (Phase 1) |
| Primary | CR+CRh rate (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the complete remission (CR) and complete remission with partial hematologic recovery (CRh) rate (Phase 2 \[Cohorts 2A-2C\]) |
| Primary | Number of participants with TEAEs (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Assessed by the NCI CTCAE version 5.0 (Phase 2 \[Cohorts 2A-2C\]) |
| Primary | Cmax (Phase 2 [Cohort 2D]) | Approximately 3 years | Cmax of revumenib (Phase 2 \[Cohort 2D\]) |
| Primary | AUC0-tau (Phase 2 [Cohort 2D]) | Approximately 3 years | Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau) of revumenib (Phase 2 \[Cohort 2D\]) |
| Secondary | Transfusion independence (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Transfusion independence is defined as any transfusion-free period lasting for at least 56 consecutive days |
| Secondary | CRc rate (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the composite definition of complete remission (CRc) rate (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | ORR (CRc+ morphological leukemia-free state [MLFS] + partial remission [PR]) (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the overall response rate (ORR) of revumenib (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | TTR (Phase 2 [Cohorts 2A-2C]) | Approximately 34 months | To assess the time to response (TTR) of revumenib (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | DOR (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the duration of response (DOR) of revumenib (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | EFS (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | To assess the event free survival (EFS) of revumenib (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | OS (Phase 2 [Cohorts 2A-2C]) | Approximately 5 years | To assess overall survival (OS) of revumenib (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | Cmax (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Cmax of revumenib and relevant metabolites (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | Tmax (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | Tmax of revumenib and relevant metabolites (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | AUC0-t (Phase 2 [Cohorts 2A-2C]) | Approximately 3 years | AUC0-t of revumenib and relevant metabolites (Phase 2 \[Cohorts 2A-2C\]) |
| Secondary | Number of participants with TEAEs (Phase 2 [Cohort 2D]) | Approximately 3 years | Assessed by the NCI CTCAE version 5.0 (Phase 2 \[Cohort 2D\])) |
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/NCT04065399/registered