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.

NCT ID: NCT00298779

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Tumors Non-Hodgkins's Lymphoma

Keywords

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patients with advanced solid tumors or Non-Hodgkins's Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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omeprazole and bortezomib

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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26866138-CAN-1001

Identifier Type: -

Identifier Source: org_study_id

NCT00107302

Identifier Type: -

Identifier Source: nct_alias