RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

Study Overview
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Brief Summary
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To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

Official Title
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A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

Conditions
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Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma

Intervention / Treatment
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* Drug: RAD001


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ≥ 18 years old. Patients with metastatic papillary renal cell carcinoma, type I or II. Patients with at least one measurable lesion. Patients with an ECOG Performance Status ≤1. Adequate bone marrow function. Adequate liver function. Adequate renal function. Adequate lipid profile. Exclusion criteria: Patients who had radiation therapy within 28 days prior to start of study. Patients who have received prior systemic treatment for their metastatic RCC. Patients who received prior therapy with VEGF pathway inhibitor. Patients who have previously received systemic mTOR inhibitors. Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients. Patients with uncontrolled central nervous system (CNS) metastases. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. Patients with a known history of HIV seropositivity. Patients with autoimmune hepatitis. Patients with an active, bleeding diathesis. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. Patients unwilling to or unable to comply with the protocol.

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>two 5 mg tablets of everolimus orally, once daily | Drug: RAD001<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months. | PFSR at 6 months based on central review | 6 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (SD + PR + CR) | DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR | 6 mos | 
| Objective Response Rate | ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression | End of trial | 
| Duration of Response | The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause. | End of trial | 
| Median Progression Free Survival | PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause. | End of trial | 
| Incidence of Adverse Events, Serious Adverse Events, and Death. |  | End of trial | 

 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 carcinoma, papillary cell renal carcinoma, adults, everolimus