Overview

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.

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Millennium Pharmaceuticals, Inc.

Collaborator:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Treatments:

Bortezomib
Omeprazole

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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