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Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial

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ClinicalTrials.gov Identifier: NCT00640692
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : March 21, 2008
Last Update Posted : September 21, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
Oregon Health and Science University

Brief Summary:
The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Condition or disease
Gastrointestinal Neoplasm

Detailed Description:
In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Kinase Genotyping of Gastrointestinal Stromal Tumors (GIST) From Patients Enrolled in the A6181112 Phase IIIb Trial at Participating U.S. and Ex-U.S. Medical Centers
Study Start Date : December 2007
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : April 2011


Group/Cohort
1
2



Biospecimen Retention:   Samples With DNA
Genomic DNA from tumor samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in Pfizer A6181112
Criteria

Inclusion Criteria:

  • Patients enrolled in Pfizer A6181112

Exclusion Criteria:

  • Patients who do not consent for analysis of their tumor in this companion study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640692


Sponsors and Collaborators
Oregon Health and Science University
Pfizer
Investigators
Principal Investigator: Christopher L Corless, MD, PhD Oregon Health and Science University

Additional Information:
Responsible Party: Christopher Corless, MD, PhD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00640692     History of Changes
Other Study ID Numbers: Pfizer GIST Genotyping Study
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Oregon Health and Science University:
Gastrointestinal stromal tumor
GIST
Sunitinib
Imatinib

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site