A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT01829841|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : May 3, 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 compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Cancer Metastatic Renal Cell Cancer||Drug: Famitinib Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Positive-controlled, Double-blind, Multicenter, Phase II Study of Famitinib as First/Second Line Treatment in Patients With Advanced Metastatic Renal Cell Cancer|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2016|
Famitinib 25 mg qd p.o., 6 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Famitinib 25 mg p.o. qd
Active Comparator: Sunitinib
Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Sunitinib 50 mg p.o. qd
- Objective Response Rate [ Time Frame: 18 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: 42-day cycle visit until disease progress ]
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]
- body vitals, laboratory parameters [ 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): NCT01829841
|Cancer Institute and Hospital Chinese Academy of Medical Sciences|
|Beijing, China, 100021|
|Study Chair:||Jinwan Wang, M.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Study Chair:||Jianhui Ma, M.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|