Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
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|ClinicalTrials.gov Identifier: NCT00568750|
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : June 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: dasatinib||Phase 2|
- To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial|
|Actual Study Start Date :||January 22, 2008|
|Actual Primary Completion Date :||January 18, 2012|
|Actual Study Completion Date :||May 16, 2018|
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).
Other Name: Sprycel
- Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria [ Time Frame: at 4 weeks compared to baseline ]
- Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ]
- Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ]
- Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ]
- Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ]
- Progression-free survival [ Time Frame: calculated from registration until progression or death ]
- Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ]
- Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ]
- Adverse drug reactions according to NCI CTCAE v3.0 [ Time Frame: Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568750
|Study Chair:||Michael Montemurro, MD||Centre Hospitalier Universitaire Vaudois|