A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02336724|
Recruitment Status : Unknown
Verified January 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : April 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: Famitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label, Multicenter, Phase II Study of Famitinib in Patients With Gastrointestinal Stromal Tumor|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
25 mg qd p.o.,28 days as one cycle,treatment discontinued when disease progression determined or intolerable toxicity or patients withdrawal of consent
- Disease Control Rate [ Time Frame: 12 weeks ]
- 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 ]
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): NCT02336724
|Nanjing Bayi Hospital|
|Nanjing, Jiangsu, China|