Back to resultsA Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
Primary Purpose
Renal Cell Cancer, Metastatic Renal Cell Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Famitinib
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Cancer focused on measuring MRCC, Metastatic Renal Cell Cancer, Famitinib, Sunitinib
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
Sites / Locations
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Famitinib
Sunitinib
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Objective Response Rate
Secondary Outcome Measures
Progress free survival (PFS)
Disease Control Rate (DCR)
Overall Survival (OS)
Quality of Life
Number of Participants with Adverse Events as a Measure of Safety
Full Information
NCT ID
NCT01829841
First Posted
April 8, 2013
Last Updated
May 1, 2018
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01829841
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Cancer, Metastatic Renal Cell Cancer
Keywords
MRCC, Metastatic Renal Cell Cancer, Famitinib, Sunitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Famitinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Sunitinib
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Famitinib
Intervention Description
Famitinib 25 mg p.o. qd
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
Sunitinib 50 mg p.o. qd
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Progress free survival (PFS)
Time Frame
3 years
Title
Disease Control Rate (DCR)
Time Frame
3 years
Title
Overall Survival (OS)
Time Frame
3 years
Title
Quality of Life
Time Frame
42-day cycle visit until disease progress
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
body vitals, laboratory parameters
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jianhui Ma, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute and Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
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