Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumor; Metastatic Cancer
• Interventions: Drug: imatinib mesylate

• Registration Number: NCT00764595
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imatinib mesylate	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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.

Secondary Outcome Measures

Name	Time	Method
Tumor response	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	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	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.

Trial Locations

Locations (36)

Aichi Cancer Center; 🇯🇵 Nagoya, Aichi, Japan

Aichi Medical University; 🇯🇵 Nagoya, Aichi, Japan

Hirosaki University, School of Medicine; 🇯🇵 Hirosaki, Aomori, Japan

National Hospital Organization Kure Medical Center; 🇯🇵 Kure, Hiroshima, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama, Kanagawa, Japan

International Goodwill Hospital; 🇯🇵 Yokohama, Kanagawa, Japan

Kochi Medical School; 🇯🇵 Nankoku, Kochi, Japan

Kyoto Second Red Cross Hospital; 🇯🇵 Kanigyou-ku, Kyoto, Japan

University of Miyazaki Hospital; 🇯🇵 Kiyotake, Miyazaki, Japan

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