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TumorsPhase 1NCT00298779

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.

A Phase 1 study testing omeprazole and bortezomib in people with Tumors and Non-Hodgkins's Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Non-Hodgkins's Lymphoma
What is being tested?
omeprazole and bortezomib
How many people
20 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

-

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

Other trials in United States

About this study

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

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.

Being tested
omeprazole and bortezomib
Keywords
patients with advanced solid tumors or Non-Hodgkins's Lymphoma
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • omeprazole and bortezomibDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: completion of cycle 2 - Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2006 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00298779
Sponsor's protocol ID
26866138-CAN-1001
Status last verified
Jun 2008
First submitted
1 Mar 2006
Last updated
6 Jun 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing omeprazole and bortezomib in people with Tumors and Non-Hodgkins's Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00298779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2008.

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