Status:
COMPLETED
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Renal Cell Cancer
Metastatic Renal Cell Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01829841
Start Date
May 1 2011
End Date
May 1 2016
Last Update
May 3 2018
Active Locations (1)
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1
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021