Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
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|ClinicalTrials.gov Identifier: NCT01392235|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 18, 2018
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.
PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Nasopharyngeal Carcinoma Metastatic Nasopharyngeal Carcinoma||Drug: Famitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||August 2016|
|Experimental: Drug: Famitinib||
25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- CBR(Clinical Benefit Rate) [ Time Frame: 12 weeks ]To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC
- ORR (Objective Response Rate) [ Time Frame: 12 weeks ]
- PFS(Progress Free Survival) [ Time Frame: 3 years ]
- DCR(Disease Control Rate) [ Time Frame: 12 weeks ]
- OS(Sverall Survival) [ Time Frame: 3 years ]
- To evaluate the safety and tolerability [ Time Frame: 3 years ]Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.
- QoL(Quality of Life) [ 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): NCT01392235
|Department of Medical Oncology, Cancer Center, Sun Yet-sen University|
|Guangzhou, Guangdong, China, 510060|