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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


N/A
18 Years
80 Years
Not Enrolling
Both
Gastrointestinal Neoplasm

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Trial Information

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


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.


Inclusion Criteria:



- Patients enrolled in Pfizer A6181112

Exclusion Criteria:

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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Christopher L Corless, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

Pfizer GIST Genotyping Study

NCT ID:

NCT00640692

Start Date:

December 2007

Completion Date:

April 2011

Related Keywords:

  • Gastrointestinal Neoplasm
  • Gastrointestinal stromal tumor
  • GIST
  • Sunitinib
  • Imatinib
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Stromal Tumors

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