Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00640692
Study type Observational
Source Oregon Health and Science University
Contact
Status Withdrawn
Phase
Start date December 2007
Completion date April 2011

See also
  Status Clinical Trial Phase
Approved for marketing NCT00094029 - A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248 N/A
Not yet recruiting NCT06134687 - Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection N/A
Completed NCT01621295 - Assessing the Patient Experience in Cancer Care N/A
Withdrawn NCT03538613 - Study of People With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System Phase 1/Phase 2
Completed NCT02785783 - Endoringsā„¢ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection N/A
Completed NCT05172635 - Primary Tumour Response to Induction Chemotherapy in Synchronously Metastasized Colorectal Cancer
Completed NCT01129310 - First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer. Phase 2
Completed NCT03411915 - A Study of XmAb®18087 in Subjects With NET and GIST Phase 1
Completed NCT00052962 - Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis Phase 3
Recruiting NCT06159634 - Traction vs. No Traction in Colonic ESD N/A
Completed NCT05320029 - Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis N/A
Completed NCT00465725 - A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors Phase 1