NCT00568750

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	dasatinib	Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).

Timeline

• Start date: 2008-01-22
• Primary completion: 2012-01-18
• Completion: 2018-05-16
• First posted: 2007-12-06
• Last updated: 2019-06-17

Locations

18 sites across 4 countries: Finland, France, Germany, Switzerland