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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 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 107 participants.
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.
Interventions
- DRUG Milademetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2013-07-11 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01877382
The ClinicalTrials.gov registry entry for NCT01877382 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 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 1 intervention - of which Milademetan is the first listed.
NCT01877382 reports 0 study locations.
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.
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