Open-Label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of VELCADE in Patients With Either Advanced Solid Tumors or Non-Hodgkin's Lymphoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298779
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : June 6, 2008
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Millennium Pharmaceuticals, Inc.

Brief Summary:
This is an open-label, randomized, multiple-dose, multicenter Pharmacokinetics drug-drug interaction study in patients with advanced solid tumors, including non-Hodgkin's lymphoma, who are in need of anti-tumor therapy. In addition, the impact of omeprazole on the pharmacodynamics of VELCADE will also be evaluated.

Condition or disease Intervention/treatment Phase
Tumors Non-Hodgkins's Lymphoma Drug: omeprazole and bortezomib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Effect of Omeprazole Administration on the Pharmacokinetics of VELCADE in Subjects With Either Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. The investigator will determine the patient's response to VELCADE treatment following completion of Cycle 2 (Day 21). [ Time Frame: completion of cycle 2 - Day 21 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:1) Male or female at least 18 y/o 2)Weigh >/= 50 kg (110lbs) and a BMI of </= 28kg/m2;3)life expectancy >/= 3 mos; 4)Karnofsky Performance Status >/=70%; 5)Women must be menopausal. 3)Men must agree to use an acceptable method of contraception for the duration of the study.4)Must sign an informed consent document indicating understanding of the purpose and procedures required for the study;5)informed consent for genetic testing 6)Subjects have advanced solid tumor (including non-Hodgkin's lymphoma).7)resolution of reversible toxicities considered related to any prior antineoplastic therapies before entry; 8)must be able to swallow capsules whole; -

Exclusion Criteria:1)Prior exposure to VELCADE.2)Has known hypersensitivity or intolerance to omeprazole, boron, mannitol or heparin. 3)Medical history of of liver or renal insufficiency; significant cardiac, vascular, pulmonary, GI, endocrine, neurologic, rheumatologic, pyschiatric or metabolic disturbances. 4)Uncontrolled diabetes. 5)history of hypotension or decreased blood pressure;6)Uncontrolled or severe cardiovascular disease incl. myocardial infarction within 6 mos of enrollment; 7)History of alcohol/drug abuse. 8)Presence of HIV antibodies, hepatitis C antibodies or hepatitis B. 9)active systemic infection requiring treatment; 10)Pregnant or breastfeeding' 11)neuropathy >/= Gr.1; 12)transfusion dependence; 12)pre-planned surgeries or procedures that would interfere with conduct of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298779

United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier: NCT00298779     History of Changes
Obsolete Identifiers: NCT00107302
Other Study ID Numbers: 26866138-CAN-1001
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by Millennium Pharmaceuticals, Inc.:
patients with advanced solid tumors or Non-Hodgkins's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action