drugset / Trial / NCT01801436

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma

NCT01801436

Phase 3 Completed 14 enrolled Johnson & Johnson Taiwan Ltd
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

Timeline

Start
2006-12
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2

Indications