Metastatic Renal Cell Cancer, Renal Cell Cancer
Conditions
Keywords
MRCC, Metastatic Renal Cell Cancer, Famitinib, Sunitinib
Brief summary
* 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.
Interventions
DRUGSunitinib
Sunitinib 50 mg p.o. qd
DRUGFamitinib
Famitinib 25 mg p.o. qd
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | 3 years |
| Disease Control Rate (DCR) | 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 |
| Overall Survival (OS) | 3 years |
Other
| Measure | Time frame |
|---|---|
| body vitals, laboratory parameters | 3 years |
Countries
China
Outcome results
None listed