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DNA Analysis of Blood Samples From Patients With Cancer Previously Treated With Imatinib Mesylate
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on May 9, 2009.   Last Updated on May 16, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00897000
  Purpose

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is evaluating changes in DNA using blood samples from patients with cancer previously treated with imatinib mesylate.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: imatinib mesylate
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Observational
Official Title: Analysis of ABCG2 Genotype in Gleevec Treated Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (C421A) in ABCG2 and Response to Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics
MedlinePlus related topics: Cancer
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of imatinib mesylate pharmacokinetics with C421A polymorphism in the ABCG2 gene [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of side effects from imatinib mesylate with C421A polymorphism in the ABCG2 gene [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2005
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the relationship between C421A polymorphism in the ABCG2 gene and pharmacokinetics of imatinib mesylate in patients with cancer.

Secondary

  • Evaluate the relationship between C421A polymorphism in the ABCG2 gene and side effects from imatinib mesylate in these patients.

OUTLINE: This is a pilot, retrospective, multicenter study.

DNA is extracted from plasma samples previously collected from patients treated on imatinib mesylate clinical trials and is analyzed for ABCG2 genotype (specifically C421A polymorphism) by PCR and sequencing. Patient data (including patient code, disease state, weight, height, body surface area, age, race, drug, dose level, absolute dose, administration duration, administration frequency, adverse effects, response, and concomitant medications) is provided by the collaborating institution.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Previously enrolled on an imatinib mesylate clinical trial

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897000

Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: William D. Figg, PharmD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00897000     History of Changes
Other Study ID Numbers: CDR0000416133, NCI-05-C-N090
Study First Received: May 9, 2009
Last Updated: May 16, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012



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