Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Study Overview
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Brief Summary
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Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

Detailed Description
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Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. The trial of comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS) was an international randomized Phase III study designed for registration purposes. This trial randomized 723 metastatic renal cell carcinoma patients with any prognostic features to axitinib or sorafenib in the second-line setting and demonstrated significant clinical benefit of axitinib. Aim of present FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

Official Title
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Evaluation of the Safety and Efficacy of Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Conditions
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Carcinoma, Renal Cell, Clear Cell Renal Cell Carcinoma

Intervention / Treatment
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* Drug: axitinib


Participation Criteria
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Eligibility Criteria
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Principle Inclusion Criteria: Histologic confirmation of Renal cell carcinoma with a clear cell component Patients must have measurable disease Previous treatment with sunitinib or pazopanib Favorable prognosis according to IMDC criteria Must have available tumor tissue for submission Subjects must also meet various laboratory parameters for inclusion Patients must give written informed consent prior to initiation of therapy Exclusion Criteria: Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events Patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: axitinib<br>Patients will receive axitinib. | Drug: axitinib<br>* Initial dose of axitinib: 5 mg orally twice a day. Maintenance dose of axitinib: Increase or decrease dose based on individual safety and tolerability. Dose range of axitinib: 2 to 10 mg twice a day.<br>* Other names: Inlyta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 24 months | 
| Overall survival |  | 24 months | 
| Rate of treatment-related serious adverse events | Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 | 24 months |