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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00640692
First received: March 18, 2008
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Gastrointestinal Neoplasm

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Biospecimen Retention:   Samples With DNA

Genomic DNA from tumor samples


Estimated Enrollment: 120
Study Start Date: December 2007
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640692

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

Additional Information:
Pfizer A6181112 phase IIIb trial  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: March 18, 2008
Last Updated: September 18, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Stromal Tumors
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013