Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Novartis

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Imatinib Mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171977

CSTI571BJP07

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Imatinib Mesylate

Experimental group

Description:

400 mg once per day

Treatment:

Drug: Imatinib Mesylate