SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)
|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Recruitment Status : Withdrawn (Supporting company withdrew interest)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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342600
|Principal Investigator:||Kristen Ganjoo, MD||Stanford University|