Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedAugust 7, 2012
August 1, 2012
4.8 years
September 13, 2005
August 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy
3 years
Secondary Outcomes (2)
To evaluate overall survival, relapse free
3 years
Safety
3 years
Study Arms (1)
Imatinib Mesylate
EXPERIMENTAL400 mg once per day
Interventions
Eligibility Criteria
You may qualify if:
- underwent macroscopically curative resection;
- immunohistochemically confirmed KIT (CD117)-positive tumors;
- judged as being high-risk according to the criteria for risk classification
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Tokyo, Japan
Related Publications (2)
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.
PMID: 22105894DERIVEDEssat 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.
PMID: 21387287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
July 1, 2004
Primary Completion
April 1, 2009
Last Updated
August 7, 2012
Record last verified: 2012-08