Non Hodgkin Lymphoma Clinical Trial

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.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:1) Male or female at least 18 y/o 2)Weigh >/= 50 kg (110lbs) and a BMI of /= 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

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Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT00298779

Recruitment Status:

Completed

Sponsor:

Millennium Pharmaceuticals, Inc.

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There is 1 Location for this study

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Mary Crowley Medical Research Center
Dallas Texas, 75246, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT00298779

Recruitment Status:

Completed

Sponsor:


Millennium Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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