Clinical trial NCT01829841: A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Metastatic Renal Cell Cancer
Keywords: MRCC
Metastatic Renal Cell Cancer
Famitinib
Sunitinib
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2013-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 18 weeks
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: 3 years
measure: Disease Control Rate (DCR)
timeFrame: 3 years
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Quality of Life
timeFrame: 42-day cycle visit until disease progress
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 3 years
Other outcomes:
measure: body vitals, laboratory parameters
timeFrame: 3 years
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jinwan Wang, M.D
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianhui Ma, M.D
role: STUDY_CHAIR
References: