Clinical Trial: A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Single Arm, Open Label, Multicenter, Phase II Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
Brief Summary:
Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with advanced or metastatic gastrointestinal stromal tumor who failed from imatinib therapy.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome: Disease Control Rate [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Response Rate [ Time Frame: 12 weeks ]
- Progression free survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 96 months ]
- Incidence of adverse events [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: January 8, 2015
Date Started: March 2012
Date Completion: June 2016
Last Updated: January 31, 2016
Last Verified: January 2016
