To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Ghent, Belgium
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
Time frame: 6 mos
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: End of trial
Incidence of Adverse Events, Serious Adverse Events, and Death.
Time frame: End of trial
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Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Münster, Germany
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