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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors, Non-Hodgkins's Lymphoma

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Trial Information

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


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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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The investigator will determine the patient's response to VELCADE treatment following completion of Cycle 2 (Day 21).

Outcome Time Frame:

completion of cycle 2 - Day 21

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

26866138-CAN-1001

NCT ID:

NCT00298779

Start Date:

Completion Date:

Related Keywords:

  • Tumors
  • Non-Hodgkins's Lymphoma
  • patients with advanced solid tumors or Non-Hodgkins's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Mary Crowley Medical Research CenterDallas, Texas  75246