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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 is a Phase 1 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 74 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02319369
The ClinicalTrials.gov registry entry for NCT02319369 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Milademetan is the first listed.
NCT02319369 reports 0 study locations.
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.
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