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

Phase 2

Completed

• Conditions: Adenocarcinoma; Renal Cell; Non Clear Cell Renal Carcinoma; Carcinoma; Papillary Cell Renal Carcinoma
• Interventions: Drug: RAD001

• Registration Number: NCT00688753
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-03
• Study Start: 2009-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-21
• Results First Submitted QC: 2015-10-21
• Results First Posted: 2015-11-26
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAD001	RAD001	two 5 mg tablets of everolimus orally, once daily

Primary Outcome Measures

Name	Time	Method
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.	6 mos	PFSR at 6 months based on central review

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (SD + PR + CR)	6 mos	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
Objective Response Rate	End of trial	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
Duration of Response	End of trial	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.
Median Progression Free Survival	End of trial	PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
Incidence of Adverse Events, Serious Adverse Events, and Death.	End of trial

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Barcelona, Spain