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.

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00298779
First received: March 1, 2006
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Tumors
Non-Hodgkins's Lymphoma
Drug: omeprazole and bortezomib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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 NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298779

Locations
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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298779     History of Changes
Obsolete Identifiers: NCT00107302
Other Study ID Numbers: 26866138-CAN-1001
Study First Received: March 1, 2006
Last Updated: June 4, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014