Overview
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
Status:
Completed
Completed
Trial end date:
2016-05-01
2016-05-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical SciencesTreatments:
Sunitinib
Criteria
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