Back to resultsPost-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Imatinib Mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring GIST, Imatinib, Postoperative Adjuvant
Eligibility Criteria
Inclusion Criteria: underwent macroscopically curative resection; immunohistochemically confirmed KIT (CD117)-positive tumors; judged as being high-risk according to the criteria for risk classification Exclusion Criteria: synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years; received therapy with Imatinib Mesylate prior to study entry; cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria) Other protocol-defined inclusion / exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imatinib Mesylate
Arm Description
400 mg once per day
Outcomes
Primary Outcome Measures
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
Secondary Outcome Measures
To evaluate overall survival, relapse free
Safety
Full Information
NCT ID
NCT00171977
First Posted
September 13, 2005
Last Updated
August 6, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00171977
Brief Title
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Official Title
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
GIST, Imatinib, Postoperative Adjuvant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imatinib Mesylate
Arm Type
Experimental
Arm Description
400 mg once per day
Intervention Type
Drug
Intervention Name(s)
Imatinib Mesylate
Other Intervention Name(s)
Gleevec/Glivec, STI571
Primary Outcome Measure Information:
Title
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To evaluate overall survival, relapse free
Time Frame
3 years
Title
Safety
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
underwent macroscopically curative resection;
immunohistochemically confirmed KIT (CD117)-positive tumors;
judged as being high-risk according to the criteria for risk classification
Exclusion Criteria:
synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
received therapy with Imatinib Mesylate prior to study entry;
cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
Other protocol-defined inclusion / exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22105894
Citation
Kanda T, Nishida T, Wada N, Kobayashi O, Yamamoto M, Sawaki A, Boku N, Koseki M, Doi T, Toh Y, Kakeji Y, Sugiyama T, Komatsu Y, Kikuchi S, Ogoshi K, Katai H, Miyachi K, Hirota S, Ohtsu A. Adjuvant therapy with imatinib mesylate after resection of primary high-risk gastrointestinal stromal tumors in Japanese patients. Int J Clin Oncol. 2013 Feb;18(1):38-45. doi: 10.1007/s10147-011-0339-7. Epub 2011 Nov 23.
Results Reference
derived
PubMed Identifier
21387287
Citation
Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14. doi: 10.1002/ijc.25827.
Results Reference
derived
Learn more about this trial
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
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