A Study of Famitinib in Patients With Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumor
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|ClinicalTrials.gov Identifier: NCT01994213|
Recruitment Status : Terminated (The applicant decided to close the study)
First Posted : November 25, 2013
Last Update Posted : January 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteropancreatic Neuroendocrine Tumor||Drug: Famitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||May 2016|
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
- 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 ]
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): NCT01994213
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Principal Investigator:||Jinwan Wang, M.D.||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|