Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02319369 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
A Phase 1 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT02319369: Clinical Trial Phase 1 study, sponsored by Daiichi Sankyo.
NCT02319369 is a Phase 1 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02319369, a Phase 1 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
This study will take place in parts: * Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules * Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine (AZA), with different dose schedules The recommended dose for Part 2 will be selected. * Dose Expansion (Part 2): After Part 1A, participants will receive the recommended Part 2 dose schedule. There will be three groups - those with: 1. refractory or relapsed acute myelogenous leukemia (AML) 2. newly diagnosed AML unfit for intensive chemotherapy 3. high-risk myelodysplastic syndrome (MDS) * End-of-Study Follow-Up: Safety information will be collected until 30 days after the last treatment. This is the end of the study. The recommended dose for the next study will be selected.
Primary Outcome
A DLT was defined as any treatment-emergent adverse event not attributable to disease or disease-related processes occurring during the observation period (Cycle 1) in each dose-level cohort and is Grade (Gr) 3 or higher according to NCI CTCAE Version 5.0 (Version 4.03 before 01 Apr 2018), with these exceptions: for elevations in hepatic function enzymes, a DLT is defined as: Gr ≥3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels lasting \>3 days; AST/ALT \>5 × ULN if accom
Interventions
- DRUG Milademetan
- DRUG AZA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2014-11-25 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 1 |
Why NCT02319369 stopped before completion
NCT02319369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Milademetan is the first listed.
NCT02319369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02319369 about?
NCT02319369 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)". This study will take place in parts: * Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules * Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine (AZA), with different dose schedules The recommended dose for Part 2...
What is the current status of trial NCT02319369?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2014-11-25. Estimated completion is 2020-08-21.
What interventions are being tested in trial NCT02319369?
The interventions under investigation include: Milademetan (DRUG), AZA (DRUG).
Who is sponsoring clinical trial NCT02319369?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02319369's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03422731 · 74 participants · Early Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
- NCT03804853 · 74 participants · NA
Rehabilitation Following Reverse Total Shoulder Arthroplasty
- NCT04065776 · 74 participants · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
- NCT04771156 · 74 participants · Phase 4
Ketorolac in Palatoplasty
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI