Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial
NCT00640692
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Gastrointestinal Neoplasm
Sex
Females and Males
Age
18-80 years
Inclusion Criteria
Show details
- Patients enrolled in Pfizer A6181112
Exclusion Criteria
Show details
- Patients who do not consent for analysis of their tumor in this companion study
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ALL GENDERS
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- Duarte, California
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- Caracas, Distrito Capital
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial | |||
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 | |||
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. | |||
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 | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Genomic DNA from tumor samples | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients enrolled in Pfizer A6181112 | |||
Condition | Gastrointestinal Neoplasm | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Withdrawn | |||
Actual Enrollment | 0 | |||
Original Estimated Enrollment | 120 | |||
Estimated Study Completion Date | April 2011 | |||
Estimated Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number | NCT00640692 | |||
Other Study ID Numbers | Pfizer GIST Genotyping Study | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Oregon Health and Science University | |||
Study Sponsor | Oregon Health and Science University | |||
Collaborators | Pfizer | |||
Investigators |
| |||
PRS Account | Oregon Health and Science University | |||
Verification Date | October 2019 |