NCT00608907

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this Phase I study is to evaluate the effect of the co-administration of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4 inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.

Conditions

• Multiple Myeloma
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib	1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
DRUG	bortezomib, rifampicin	bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3
DRUG	bortezomib, dexamethasone	bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2008-02-06
• Last updated: 2012-01-30
• Results posted: 2011-07-13

Locations

9 sites across 5 countries: Israel, Italy, Poland, South Africa, United Kingdom