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NCT02579824 · ClinicalTrials.gov registry record · Phase 1
Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02579824: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02579824 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579824, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come back) and/or refractory (has not responded to treatment). The goal of Part 2 of this clinical research study is to continue to study the safety of the highest tolerable dose found in Part 1 of the study.
Primary Outcome
MTD defined as the highest dose at which six subjects have been treated and less than two subjects experienced dose limiting toxicity (DLT) within the first cycle of treatment. DLT defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the observation period (Cycle 1) in each dose-level cohort per NCI-CTCAE v4.
Interventions
- DRUG DS-3032b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-08-30 |
| Est. Completion | 2019-11-07 |
| Phase | Phase 1 |
Why NCT02579824 stopped before completion
NCT02579824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which DS-3032b is the first listed.
NCT02579824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02579824 about?
NCT02579824 is a clinical study titled "Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma". This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come back) and/or refractory (has not res...
What is the current status of trial NCT02579824?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-08-30. Estimated completion is 2019-11-07.
What interventions are being tested in trial NCT02579824?
The interventions under investigation include: DS-3032b (DRUG).
Who is sponsoring clinical trial NCT02579824?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02579824's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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
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