RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)

Study Overview
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Brief Summary
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To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma

Official Title
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A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: RAD001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly) Subjects with metastatic legion Subjects aged 18 years or older Subjects whose ECOG performance status is 0 or 1 Subjects who have laboratory value below; Hematology Neutrophil >= 1.5 x 109/L Platelet >= 75 x 109/L Hemoglobin >= 9 g/dL Liver function tests Total bilirubin ≤ 1.5 xULN AST, ALT ≤ 2.5 xULN Alkaline phosphatase ≤ 2.5 xULN Renal function tests Creatinine clearance >= 30 mL/min Subjects who understand and provide a written informed consent Exclusion Criteria: Subjects who have been administered an mTOR inhibitor Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative Subjects who participated in a clinical study using the study medication within 30 days before randomization Subjects with clinically uncontrolled central nervous system (CNS) metastasis Subjects with life expectancy of less than 3 months Subjects with interstitial pulmonary disease Subjects whose QTc interval is prolonged (QTc > 450 msec for male or > 470 msec for female) Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug

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: RAD001<br>RAD001 10mg/day | Drug: RAD001<br>* RAD001 10mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | It is the time from treatment initiation until disease progression. | 2 months, 4 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | It is the percentage of patients whose cancer shrinks or disappears after treatment. | 2 months, 4 months, 6 months | 
| Disease-control rate | It is the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. | 2 months, 4 months, 6 months | 
| Overall survival | The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive. | 2 months, 4 months, 6 months | 
| Metabolic response rate by FDG-PET | It is assesed target lesions and non- target lesions by FDG-PET. | 2 months, 4 months, 6 months | 
| Safety |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma