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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
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
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
Hematology Institute - Davidoff Center - Rabin Medical Center
Petah Tikva, Israel
Divisione di Ematologia - Ospedale S Eugenio - P. le dell'Umanesimo
Rome, Italy
Medical Academy - Dept of Hematology and Transplantology
Gdansk, Poland
Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours
Time frame: Cycle 3 day 14 (72 hours post last dose)
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Klinika Nowotworow Ukladu - Chlonnego - Centrum Onkologii - Instytut
Warsaw, Poland
Hematological Oncology
Parow, Cape Town, South Africa
Department of Hematology - University of the Free State
Bloemfontein, South Africa
Department of Medical Oncology - Ward 51 - Pretoria Academic Hospital
Pretoria, South Africa
Plymouth Hospitals NHS Trust - Derriford Hospital
Derriford, Plymouth, United Kingdom
Hematology Department Combined Laboratories - Derriford Hospital
Plymouth, United Kingdom