Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Papillary Renal Cell Carcinoma

Chromophil Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

two 5 mg tablets of everolimus orally, once daily

RAD001

Novartis Pharmaceuticals

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

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

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

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

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

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.

PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.

two 5 mg tablets orally, once daily at the same time every day immediately after a meal

All Patients

RAD001 10 mg

Age, Categorical

Age, Continuous

Sex: Female, Male

Clinical Disclosure Office

(PPFF Set, N=44)

(PPSet, N=66)

(ITT Set, N=86)

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.

PP set

ITT set

Disease Control Rate (SD + PR + CR)

PP Set

ITT Set

Objective Response Rate

local review PP set

local review ITT set

In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria

Spots Global Cancer Trial Database for papillary cell renal carcinoma