A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Cell Cancer, Metastatic Renal Cell Cancer

Intervention / Treatment
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* Drug: Famitinib
* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients) With measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy) Male or female, age ≥18 and ≤75 ECOG 0-1 Life expectancy ≥ 3 months Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed Normal major organ function Signed and dated informed consent Exclusion Criteria: Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib) Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ Participated in other clinical trials within four weeks A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction) Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease Patients with hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 440ms) and class I heart failure. Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy Previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism The preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range With a history of abuse of psychotropic drugs or mental disorders Patients with Hepatitis B or Hepatitis C History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famitinib<br>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. | Drug: Famitinib<br>* Famitinib 25 mg p.o. qd<br>|
| Active Comparator: Sunitinib<br>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. | Drug: Sunitinib<br>* Sunitinib 50 mg p.o. qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | 3 years | 
| Disease Control Rate (DCR) |  | 3 years | 
| Overall Survival (OS) |  | 3 years | 
| Quality of Life |  | 42-day cycle visit until disease progress | 
| Number of Participants with Adverse Events as a Measure of Safety |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRCC, Metastatic Renal Cell Cancer, Famitinib, Sunitinib