Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor Clinical Trial

Official title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

Status Completed

Clinical Trial Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.

Clinical Trial Description

OBJECTIVES:

Primary

• To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.

Secondary

• To determine the efficacy and safety of dasatinib in these patients.

• To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.

• To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.

• To determine the efficacy of second-line treatment with another TK-inhibitor.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years. ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

• NCT number: NCT00568750
• Study type: Interventional
• Source: Swiss Group for Clinical Cancer Research
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2008
• Completion date: May 16, 2018