NCT01912222

Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction

A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) in Patients With Advanced Solid Tumors or Hematologic Malignancies With Varying Degrees of Liver Dysfunction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.

Conditions

• Advanced Solid Tumors
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	IXAZOMIB

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-07-31
• Last updated: 2016-06-02
• Results posted: 2016-03-25

Locations

4 sites across 1 country: United States