RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
Daniel George, MD, Duke University Medical Center
First received: February 27, 2008
Last updated: February 12, 2015
Last verified: February 2015
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).
Hormone Refractory Prostate Cancer
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
- Pathologic Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]
Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index
- Progression Free Survival [ Time Frame: Patients were followed for a median of 315 days, with the last patient censored at 1309 days. ] [ Designated as safety issue: No ]
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.
- Molecular Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]
Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.
- Clinical Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
RAD001 at a dose of 10 mg PO daily
RAD001 at a dose of 10 mg PO daily
Other Name: Everolimus
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- History of solid organ or stem cell transplantation
- Also, no current use of chronic immunosuppressive therapy is allowed
- Patients with known brain metastases (or history of brain metastases)
- History of HIV, hepatitis B, or hepatitis C infection
- Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic congestive heart failure (NYHC III or greater), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT or any VT), or psychiatric illness/social situations that would limit compliance with study requirements
- History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs.
- Any unresolved bowel obstruction or diarrhea
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629525
|Duke University MEdical Center
|Durham, North Carolina, United States, 27710 |
Daniel George, MD
||Daniel J George, MD
||Duke University Health System
||Daniel George, MD, Associate Professor of Medicine, Duke University Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 27, 2008
|Results First Received:
||January 4, 2013
||February 12, 2015
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2016
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs