|
|
|
|
|
|
Sponsors and Collaborators: |
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00608907 |
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.
Condition | Intervention | Phase |
Multiple Myeloma or Non-Hodgkin's Lymphoma |
Drug: bortezomib Drug: rifampicin |
Phase I |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Lymphoma Multiple Myeloma |
Drug Information available for: | Bortezomib Rifampin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) |
Estimated Enrollment: | 45 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator
Control arm, VELCADE only
|
Drug: bortezomib
IV bolus
|
B: Experimental
Treatment Arm, VELCADE and Rifampicin
|
Drug: rifampicin
oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory values at screening:
Exclusion Criteria:
History of disallowed therapies:
Contact: Christine Colby, PharmD | 1-866-835-2233 |
Israel | |||||
Hematology Institute - Davidoff Center - Rabin Medical Center | Recruiting | ||||
Petach Tikva, Israel, 49100 | |||||
Italy | |||||
Divisione di Ematologia - Ospedale S Eugenio - P. le dell'Umanesimo | Not yet recruiting | ||||
Rome, Italy, 10001 | |||||
Poland | |||||
Medical Academy - Dept of Hematology and Transplantology | Not yet recruiting | ||||
Gdansk, Poland, 80-952 | |||||
Klinika Nowotworow Ukladu - Chlonnego - Centrum Onkologii - Instytut | Not yet recruiting | ||||
Warszawa, Poland, 02-781 | |||||
South Africa | |||||
Department of Medical Oncology - Ward 51 - Pretoria Academic Hospital | Not yet recruiting | ||||
Pretoria, South Africa, 0001 | |||||
Department of Hematology - University of the Free State | Not yet recruiting | ||||
Bloemfontein, South Africa, 9300 | |||||
South Africa, Cape Town | |||||
Hematological Oncology | Not yet recruiting | ||||
Parwow, Cape Town, South Africa | |||||
United Kingdom | |||||
Hematology Department Combined Laboratories - Derriford Hospital | Recruiting | ||||
Plymouth, United Kingdom, PL6 8DH | |||||
United Kingdom, Plymouth | |||||
Plymouth Hospitals NHS Trust - Derriford Hospital | Recruiting | ||||
Derriford, Plymouth, United Kingdom, PL68DH | |||||
Contact: Simon Rule, M.D. |
Millennium Pharmaceuticals, Inc. |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development ( Clinical Research Monitor ) |
Study ID Numbers: | 26866138-CAN-1006 |
First Received: | January 23, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00608907 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|