A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Neuroendocrine Tumor|
- Objective Response Rate [ Time Frame: 12 weeks ]
- 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 ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Famitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Famitinib 25 mg p.o. qd
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994213
|Contact: Haoyuan Jiang, Ph.D,M.D||+86 21 email@example.com|
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Contact: Jinwan Wang, M.D.|
|Principal Investigator:||Jinwan Wang, M.D.||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|