Trial · NCT03760445
HDM201 Added to CT in R/R or Newly Diagnosed AML
NCT03760445, Phase 1, Phase 2, Withdrawn, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. HDM201 Added to CT in R/R or Newly Diagnosed AML. Trials, record NCT03760445. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03760445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HDM201 Added to CT in R/R or Newly Diagnosed AML
- NCT number
- NCT03760445
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- HDM201, cytarabine, anthracycline, midostaurin, liposomal cytarabine/daunorubicin, posaconazole, midazolam
- First posted
- 2018-11-30
- Last updated
- 2020-01-09
- Other registries' IDs
- eudract:2018-003107-19
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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/NCT03760445
GET https://conductscience.org/api/trials/v1/NCT03760445/registered?page=2