NCT01877382

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
DRUG	Milademetan	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.
DRUG	Milademetan	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.

Timeline

• Start date: 2013-07-11
• Primary completion: 2020-10-08
• Completion: 2020-12-03
• First posted: 2013-06-13
• Last updated: 2025-03-27
• Results posted: 2024-07-18

Locations

5 sites across 1 country: United States