Pharmacokinetic Study of Oral IXAZOMIB in Cancer Patients With Liver Dysfunction
NCT01912222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2016-06-02
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
Interventions
- DRUG
-
IXAZOMIB
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Millennium Pharmaceuticals, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
Study Locations
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