NCT01454076

Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma

A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.

Conditions

• Nonhematologic Malignancies
• Lymphoma

Interventions

Type	Name	Description
DRUG	Ixazomib 2.5 mg	Ixazomib 2.5 mg Capsule B (Cycle 1 only)
DRUG	Ixazomib 4 mg Capsule A	Ixazomib 4 mg Capsule A (Cycle 1 only)
DRUG	Ixazomib 4 mg Capsule B	Ixazomib 4 mg Capsule B (Cycle 2 and beyond )
DRUG	Ketoconazole	Ketoconazole 400 mg tablets (Cycle 1 only)
DRUG	Rifampin	Rifampin 600 mg capsule (Cycle 1 only)
DRUG	Clarithromycin	Clarithromycin 500 mg tablets (Cycle 1 only)
DRUG	Ixazomib 4 mg Capsule B	Ixazomib 4 mg Capsule B (Cycle 1 and beyond)

Timeline

• Start date: 2011-11-10
• Primary completion: 2015-04-01
• Completion: 2016-06-16
• First posted: 2011-10-18
• Last updated: 2017-11-01
• Results posted: 2017-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study