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NCT01877382 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
NCT01877382: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01877382 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877382, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
Study Summary
This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/ pharmacodynamic (PDy) properties in participants with advanced solid tumors or lymphomas. Approximately 5 US sites are planned for Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The same sites are planned to participate for both parts.
Primary Outcome
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerged during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at pretreatment; or reemerged during treatment, having been present at baseline, but stopped prior to treatment; or worsened in severity after starting treatment relative to the pretreatment state, when the AE was continuous.
Interventions
- DRUG Milademetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2013-07-11 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 1 |
What the finished NCT01877382 record still lists
NCT01877382 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 1 intervention - of which Milademetan is the first listed.
NCT01877382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877382 about?
NCT01877382 is a clinical study titled "A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas". This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/ pharmacodynamic (PDy) properties in participants with advanced solid tumors or lympho...
What is the current status of trial NCT01877382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2013-07-11. Estimated completion is 2020-12-03.
What interventions are being tested in trial NCT01877382?
The interventions under investigation include: Milademetan (DRUG).
Who is sponsoring clinical trial NCT01877382?
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 NCT01877382's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 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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