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

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumor
• Interventions: Drug: dasatinib

• Registration Number: NCT00568750
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief 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.

Study Timeline

• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Study Start: 2008-01-22
• Primary Completion: 2012-01-18
• Study Completion: 2018-05-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib	dasatinib	-

Primary Outcome Measures

Name	Time	Method
Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria	at 4 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
Time to progression	calculated from registration until progression or death due to tumor
Best response as assessed by CT scan/MRI	according to RECIST criteria
Progression-free survival	calculated from registration until progression or death
Time to treatment failure	calculated from registration until premature trial treatment termination due to any reason
Adverse drug reactions according to NCI CTCAE v3.0	Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0.
Clinical benefit	Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST
Best response as assessed by fusion PET/CT scan	at 4 weeks
Overall survival	Overall survival will be calculated from registration until death or last follow-up, up to 5 years.

Trial Locations

Locations (18)

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Hopital Edouard Herriot - Lyon; 🇫🇷 Lyon, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Biomedicum Helsinki; 🇫🇮 Helsinki, Finland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

Saint Claraspital AG; 🇨🇭 Basel, Switzerland

Kantonsspital Bruderholz; 🇨🇭 Bruderholz, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Liestal; 🇨🇭 Liestal, Switzerland

Onkozentrum - Klinik im Park; 🇨🇭 Zurich, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland