Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-25 @ 6:55 PM
Study NCT ID:
NCT00568750
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2007-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
Sponsor:
Swiss Cancer Institute
Organization:
Study Overview
Official Title:
Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: