Status:
COMPLETED
A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Renal Cell Carcinoma
Nonclear Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* 1\. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC). * 2\. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF treatment. * 3\. Th...
Detailed Description
1. Renal Cell Carcinoma Renal cell carcinoma is a malignant tumor occurring most frequently of primary malignant tumors in kidney.1 According to Korea Central Cancer Registry (KCCR) data, renal cancer...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmation of RCC without a clear cell histologic component, e.g., papillary type, chromophobe type, medullary type or unclassified)
- Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
- Previous treatment with temsirolimus
- Measurable disease according to RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Age 18 years or older
- Adequate cardiac function
- Adequate bone marrow, hepatic, and renal function
- Hematology:
- Neutrophil same or more than 1.5 x 10\^9/L Platelet same or more than 75 x 10\^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN
- Renal function tests: Creatinine clearance same or more than 30 mL/min
- Life expectancy more than 3 months
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Exclusion
- Clear cell type RCC
- Composed of mostly sarcomatoid carcinoma
- Collecting duct type RCC
- Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
- Hypertension that cannot be controlled by medications (blood pressure 150/90 mmHg despite optimal medical therapy)
- Pregnancy or breast feeding
- Other severe acute or chronic medical or psychiatric condition
- Prior treatment on sunitinib, sorafenib, pazopanib or bevacizumab
- Uncontrolled central nerve system (CNS) metastasis (brain and/or leptomeningeal metastasis)
- Patients who require concomitant treatment with potent cytochrome P 3A4 ( CYP3A4) inducers and inhibitors
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01798446
Start Date
February 1 2013
End Date
December 1 2016
Last Update
December 8 2020
Active Locations (1)
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1
Seou National University Hospital
Seoul, South Korea, 110744