Clinical Trial: A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Single-arm, Open-label, Multicenter, Phase II Study of Famitinib as First/Second Line Treatment in Patients With Advanced or Metastatic Gastroenteropancreatic Neuro
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 Gastroenteropancreatic Neuroendocrine Tumor.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome: Objective Response Rate [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progress free survival (PFS) [ Time Frame: 3 years ]
- Disease Control Rate (DCR) [ Time Frame: 3 years ]
- Overall Survival (OS) [ Time Frame: 3 years ]
- Quality of Life [ Time Frame: 28-day cycle visit until disease progress ]
- Percent of Participants with OS of one year [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: November 19, 2013
Date Started: October 2011
Date Completion: November 2017
Last Updated: November 19, 2013
Last Verified: November 2013
