Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
NCT02214147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2018-11-15
Summary
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
Conditions
- Advanced Solid Tumors
- Relapsed/Refractory Lymphoma
Interventions
- DRUG
-
Alisertib
Alisertib will be supplied as enteric coated tablets.
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director Clinical Science · 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
- 2014-08-21
- Primary Completion
- 2016-04-05
- Completion
- 2016-07-18
Countries
- United States
Study Locations
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