Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Hormones

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

RAD001

Daniel J George, MD

The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).

This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.

RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.

Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index

Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.

The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:

Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD

Novartis Pharmaceuticals

Daniel George, MD

Associate Professor of Medicine

data were collected in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and converted to version 4.0 for Clinicaltrials.gov entry

Age, Continuous

Sex: Female, Male

Dr. Daniel George

Biochemical Response Rate

Only subjects with paired samples were included in this analysis

Pathologic Response

Progression Free Survival

Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.

Spots Global Cancer Trial Database for RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

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