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

Renal Cell Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829841
• Other study ID #: FMTN-II-MRCC
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: May 2016

Study information

• Verified date: April 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Cancer
• Renal Cell Cancer

Intervention

Drug:
• Famitinib
Famitinib 25 mg p.o. qd
• Sunitinib
Sunitinib 50 mg p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body vitals, laboratory parameters		3 years
Primary	Objective Response Rate		18 weeks
Secondary	Progress free survival (PFS)		3 years
Secondary	Disease Control Rate (DCR)		3 years
Secondary	Overall Survival (OS)		3 years
Secondary	Quality of Life		42-day cycle visit until disease progress
Secondary	Number of Participants with Adverse Events as a Measure of Safety		3 years