Role of Gene Variation in Effectiveness of Gleevec Treatment
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
2 other identifiers
observational
100
2 countries
2
Brief Summary
This study will examine DNA from cancer patients previously treated with Gleevec to look for a variation (mutation) of the ABCG2 gene that may render the drug less effective in certain patients. Gleevec is used to treat chronic myeloid leukemia and gastrointestinal tumors. Although most patients respond to treatment, many with advanced disease develop resistance to the drug. It is thought that in some patients this resistance results from the action of a protein that causes Gleevec to be pumped out of the cells, reducing its usefulness. Patients enrolled in clinical trials of Gleevec at the National Cancer Institute and at other participating institutions are eligible for this study. DNA from patients' blood samples are analyzed for the ABCG2 gene and correlated with clinical data, such as the patient's age, race, disease state, weight, height, and body surface area. It will also look at the drug dose, how often the drug is given, the duration of treatment, side effects and other medications taken.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2005
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 25, 2011
May 1, 2011
June 19, 2006
May 24, 2011
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- In this retrospective study, all cancer patients enrolled on IRB approved clinical trials of Gleevec from both the National Cancer and outside institutions will be eligible, provided that they have consented in the original consent form.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Katholieke Universiteit Leuven, U Hospitals UZ Gasthuisberg
Leuven, Belgium
Related Publications (3)
Bailey-Dell KJ, Hassel B, Doyle LA, Ross DD. Promoter characterization and genomic organization of the human breast cancer resistance protein (ATP-binding cassette transporter G2) gene. Biochim Biophys Acta. 2001 Sep 21;1520(3):234-41. doi: 10.1016/s0167-4781(01)00270-6.
PMID: 11566359BACKGROUNDBates SE, Robey R, Miyake K, Rao K, Ross DD, Litman T. The role of half-transporters in multidrug resistance. J Bioenerg Biomembr. 2001 Dec;33(6):503-11. doi: 10.1023/a:1012879205914.
PMID: 11804192BACKGROUNDLeonard GD, Polgar O, Bates SE. ABC transporters and inhibitors: new targets, new agents. Curr Opin Investig Drugs. 2002 Nov;3(11):1652-9.
PMID: 12476969BACKGROUND