CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 107 enrolled
Drug / intervention
Milademetan +1 moredrug
Likely dose
Milademetan 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01877382
NCT01877382Phase 1Completed
CompareCT.gov

A Phase 1 Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas

Daiichi Sankyo·interventional·Posted Jun 13, 2013·Updated Mar 27, 2025

In Brief

A Phase 1 clinical trial evaluating Milademetan for Advanced Solid Tumor and Lymphoma. Completed, enrolled 107 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor, Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 13, 2013
Enrollment StartJul 11, 2013
Primary CompletionOct 8, 2020
Study CompletionDec 3, 2020
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 13.1 years ago

Interventions

Milademetandrug

DS-3032b will be administered as an oral capsule. It will be supplied in 5, 20, 80, and/or 200 mg capsules individually packaged in desiccant-embedded aluminum blisters.

Milademetandrug

Milademetan will be administered as a single oral capsule or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 and/or 100 mg capsules of milademetan may be utilized.