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

NCT00608907 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	61
Start date	2007-09
Completion	2010-04

Conditions

• Multiple Myeloma
• Non-Hodgkin's Lymphoma

Interventions

• bortezomib
• bortezomib, rifampicin
• bortezomib, dexamethasone

Primary outcomes

• Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours — Cycle 3 day 14 (72 hours post last dose)

Countries

Israel, Italy, Poland, South Africa, United Kingdom