Overview

This trial is active, not recruiting.

Conditions renal cell cancer, metastatic renal cell cancer
Treatments famitinib, sunitinib
Phase phase 2
Targets VEGF, FLT-3, KIT, PDGF
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Collaborator Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Start date May 2011
End date May 2013
Trial size 150 participants
Trial identifier NCT01829841, FMTN-II-MRCC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
famitinib
Famitinib 25 mg p.o. qd
(Active Comparator)
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.
sunitinib
Sunitinib 50 mg p.o. qd

Primary Outcomes

Measure
Objective Response Rate
time frame: 18 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..