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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01829841

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)

150

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Cancer Metastatic Renal Cell Cancer	Drug: Famitinib Drug: Sunitinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Famitinib Famitinib 25 mg p.o. qd
Active Comparator: 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.	Drug: Sunitinib Sunitinib 50 mg p.o. qd

Arm

Intervention/Treatment

Experimental: 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.

Drug: Famitinib

Famitinib 25 mg p.o. qd

Active Comparator: 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.

Drug: Sunitinib

Sunitinib 50 mg p.o. qd

Outcome Measures

Primary Outcome Measures

Objective Response Rate [18 weeks]

Secondary Outcome Measures

Progress free survival (PFS) [3 years]
Disease Control Rate (DCR) [3 years]
Overall Survival (OS) [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]

Other Outcome Measures

body vitals, laboratory parameters [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute and Hospital Chinese Academy of Medical Sciences	Beijing		China	100021

Sponsors and Collaborators

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

Investigators

Study Chair: Jinwan Wang, M.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Chair: Jianhui Ma, M.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences