Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor (GISTs)
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|ClinicalTrials.gov Identifier: NCT00764595|
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : September 28, 2016
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor Metastatic Cancer||Drug: imatinib mesylate||Phase 2|
- To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: imatinib mesylate
All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient.
Drug: imatinib mesylate
Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.
- Progression-free survival [ Time Frame: 7.5 years ]Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first.
- Tumor response [ Time Frame: 48 weeks ]Tumor response is defined as best overall response by RECIST v1.0 from date of starting protocol treatment until 48 weeks after starting protocol treatment.
- Overall survival [ Time Frame: 7.5 years ]Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.
- Types and severities of adverse events [ Time Frame: 7.5 years ]Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764595
|Principal Investigator:||Tatsuo Kanda, MD||Niigata University Medical & Dental Hospital|