SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)
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|ClinicalTrials.gov Identifier: NCT02342600|
Recruitment Status : Withdrawn (Supporting company withdrew interest)
First Posted : January 21, 2015
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors||Drug: Pazopanib Drug: Trametinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SARC029: Phase II Pilot Study of Trametinib in Combination With Pazopanib in Patients With Metastatic or Local-regionally Recurrent GIST (Gastrointestinal Stromal Tumor) Refractory or Intolerant to at Least Imatinib and Sunitinib|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
Experimental: Trametinib with Pazopanib
Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.
A kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma and advanced soft tissue sarcoma who have receive prior chemotherapy.
Other Name: VotrientDrug: Trametinib
A kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Other Name: Mekinist
- Disease Control Rate (DCR) [ Time Frame: 16 weeks ]Disease Control Rate (DCR) is the percentage of patients who have achieved complete response, partial response and stable disease to study treatment
- Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]Date of first dose of drug to date of imaging demonstrating disease progression.
- Overall Survival (OS) [ Time Frame: up to 10 years ]Time from first date of drug administration to date of death from any cause
- Number and type of adverse events [ Time Frame: up to 2 years ]
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): NCT02342600
|Principal Investigator:||Kristen Ganjoo, MD||Stanford University|