SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Registration Number
- NCT02342600
- Brief Summary
This study evaluates the combination of trametinib and pazopanib in patients with advanced gastrointestinal stromal tumors (GIST).
- Detailed Description
Trametinib and pazopanib are independently approved for other cancers. Both drugs work to inhibit tumor development in different ways. Combining these drugs may lead to improved disease control. The purpose of this study is to evaluate the effect of the combination of both drugs on advanced gastrointestinal stromal tumors.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trametinib with Pazopanib Pazopanib Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle. Trametinib with Pazopanib Trametinib Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR) 16 weeks Disease Control Rate (DCR) is the percentage of patients who have achieved complete response, partial response and stable disease to study treatment
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 10 years Time from first date of drug administration to date of death from any cause
Progression Free Survival (PFS) Up to 12 months Date of first dose of drug to date of imaging demonstrating disease progression.
Number and type of adverse events up to 2 years