A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
Phase 2
Completed
- Conditions
- Metastatic Renal Cell CancerRenal Cell Cancer
- Interventions
- Registration Number
- NCT01829841
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sunitinib 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. Famitinib Famitinib 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate 18 weeks
- Secondary Outcome Measures
Name Time Method Quality of Life 42-day cycle visit until disease progress Progress free survival (PFS) 3 years Overall Survival (OS) 3 years Disease Control Rate (DCR) 3 years Number of Participants with Adverse Events as a Measure of Safety 3 years
Trial Locations
- Locations (1)
Cancer Institute and Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China