Clinical Trials Directory

Trials / Completed

CompletedNCT01953783

Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB

A Phase 1 Study of [ 14 C]-Ixazomib to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphoma

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

Summary

This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.

Conditions

Interventions

TypeNameDescription
DRUGIXAZOMIBPart A: Ixazomib 4.1 mg containing approximately 500-nCi \[14C\]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21. Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity.

Timeline

Start date
2014-03-19
Primary completion
2014-12-17
Completion
2016-02-09
First posted
2013-10-01
Last updated
2020-08-26
Results posted
2020-08-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01953783. Inclusion in this directory is not an endorsement.