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Sponsors and Collaborators: |
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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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 |
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Multiple Myeloma or Non-Hodgkin's Lymphoma |
Drug: bortezomib Drug: rifampicin |
Phase I |
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 |
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A: Active Comparator
Control arm, VELCADE only
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Drug: bortezomib
IV bolus
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B: Experimental
Treatment Arm, VELCADE and Rifampicin
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Drug: rifampicin
oral
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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. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development ( Clinical Research Monitor ) |
Study ID Numbers: | 26866138-CAN-1006 |
Study First Received: | January 23, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00608907 |
Health Authority: | United States: Food and Drug Administration |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Lymphoma, small cleaved-cell, diffuse Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Rifampin Lymphatic Diseases Hemorrhagic Disorders Multiple myeloma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
Antibiotics, Antitubercular Anti-Bacterial Agents Neoplasms Therapeutic Uses Cardiovascular Diseases Antitubercular Agents Nucleic Acid Synthesis Inhibitors Leprostatic Agents |