NCT00830869

A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

An Open-Label, Dose Escalation, Phase 1 Study of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.

Conditions

• Advanced Non-hematologic Malignancies

Interventions

Type	Name	Description
DRUG	IXAZOMIB	All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days. The first stage of the study will be initiated at a starting dose of 0.125 mg/m\^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Timeline

• Start date: 2009-03-02
• Primary completion: 2012-04-20
• Completion: 2012-04-20
• First posted: 2009-01-28
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study