Trial · NCT03760445
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 - Incidence of dose limiting toxicity (DLT) | first day of study treatment to 3 months after start of study treatment | number of DLTs by dose regimen of first line (1L) acute myeloid leukemia (AML) subjects during induction treatment; number of DLTs by dose regimen of relapsed/refractory (R/R) AML subjects during treatment |
| Primary | Part 1 - Time to DLT | first day of study treatment to 3 months after start of study treatment | time from first dose to onset of DLT by dose regimen of 1L AML and R/R AML subjects |
| Primary | Part 1 - Incidence and severity of Adverse Events (AEs) | first day of study treatment to 3 months after start of study treatment | number and grade of AEs by dose regimen of 1L AML and R/R AML subjects during DLT observation period |
| Primary | Part 2 - Incidence and severity of AEs/serious adverse events (SAEs) | first day of study treatment until 8.5 months after start of study treatment | number and grade of AEs/SAEs by expansion cohort |
| Primary | Part 2 - Percentage of participants with complete remission (CR)/CR with incomplete recovery (CRi) with adequate blood count recovery (ABCR) | first day of study treatment until 4.5 months after start of study treatment | Percentage of participants with CR/CRi with ABCR at the end of induction treatment for Expansion Cohort 1, and at the end of treatment for Expansion Cohort 4 |
| Primary | Part 2 - Incidence and severity of abnormal laboratory values | first day of study treatment until 8.5 months after start of study treatment | number and grade of abnormal laboratory results by expansion cohort |
| Primary | Part 2 - Incidence and severity of abnormal electrocardiogram (ECG) results | first day of study treatment until 8.5 months after start of study treatment | number and severity of abnormal ECG results by expansion cohort |
| Primary | Part 2 - Incidence and severity of abnormal vital signs | first day of study treatment until 8.5 months after start of study treatment | number and severity of abnormal vital signs by expansion cohort |
| Primary | Part 3 - DDI Cohort 1 HDM201 Pharmacokinetics (PK) area under the curve (AUC) | first day of HDM201 dose to 10 days after start of HDM201 | determine HDM201 AUC from time zero to the last measurable concentration sampling time (AUClast) in Cycle 1 |
| Primary | Part 3 - DDI Cohort 1 HDM201 PK maximum observed plasma concentration (Cmax) | first day of HDM201 dose to 10 days after start of HDM201 | determine HDM201 Cmax in Cycle 1 |
| Primary | Part 3 - DDI Cohort 1 HDM201 PK average plasma concentration | first day of HDM201 dose to 10 days after start of HDM201 | determine HDM201 average plasma concentration in Cycle 1 |
| Primary | Part 3 - DDI Cohort 1 HDM201 PK time of maximum observed plasma concentration (Tmax) | first day of HDM201 dose to 10 days after start of HDM201 | determine HDM201 Tmax in Cycle 1 |
| Primary | Part 3 - DDI Cohort 2: midazolam PK AUC | first dose of midazolam (Day-2) to 8 days after start of study treatment (HDM201) | determine midazolam AUC last and AUC from time zero to infinity (inf) |
| Primary | Part 3 - DDI Cohort 2: midazolam PK Cmax | first dose of midazolam (Day-2) to 8 days after start of study treatment (HDM201) | determine midazolam Cmax |
| Secondary | Part 1 +2: HDM201 PK AUC | first day of study treatment to 7.5 months after start of study treatment | determine HDM201 AUC by dose regimen in Part 1, and Expansion Cohort in Part 2 |
| Secondary | Part 1 +2: HDM201 PK Cmax | first day of study treatment to 7.5 months after start of study treatment | determine Cmax of HDM201 by dose regimen in Part 2, and Expansion Cohort in Part 2 |
| Secondary | Part 1 +2: HDM201 PK Tmax | first day of study treatment to 7.5 months after start of study treatment | determine Tmax of HDM201 by dose regimen in Part 2, and Expansion Cohort in Part 2 |
| Secondary | Part 1 - incidence of AEs/SAEs | first day of study treatment to 8.5 months after start of study treatment | number and grade of AEs/SAEs, by dose regimen for 1L AML and R/R AML subjects during study treatment + 30 days |
| Secondary | Part 2 - all Expansion Cohorts: time to platelet recovery | first day of study treatment to 7.5 months after start of study treatment | determine time to platelet recovery by Expansion Cohort for each cycle |
| Secondary | Part 2 - all Expansion Cohorts: time to neutrophil recovery | first day of study treatment to 7.5 months after start of study treatment | determine time to neutrophil recovery by Expansion Cohort for each cycle |
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.
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GET https://conductscience.org/api/trials/v1/NCT03760445/registered