| February 27, 2008 |
| September 15, 2009 |
| August 2005 |
| August 2009 (final data collection date for primary outcome measure) |
| Biochemical response rate [ Time Frame: every 4 weeks and when applicable ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00629525 on ClinicalTrials.gov Archive Site |
- Pathologic response defined as either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index [ Time Frame: screening and again at 4 weeks ] [ Designated as safety issue: No ]
- Functional extent of mTOR inhibition by changes in the phosphorylation status of S6K and CA IX protein in prostate tumors.(Molecular response). [ Time Frame: at screening and again at 4 weeks ] [ Designated as safety issue: No ]
- To identify patient subsets more likely to respond to mTOR inhibition (Predictive response) [ Time Frame: at screening and again at 4 weeks ] [ Designated as safety issue: No ]
- To determine the measurable response rate to RAD001 using RECIST criteria (Clinical response) [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| 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 |
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. |
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. |
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Hormone Refractory Prostate Cancer |
| Drug: RAD001 |
| Experimental: RAD001 |
| |
| |
| Active, not recruiting |
| 60 |
| December 2009 |
| August 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- 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 SUT 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
|
| Male |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00629525 |
| Daniel J George, MD, Duke University Medical Center |
| 7521 |
| Duke University |
| Novartis Pharmaceuticals |
| Principal Investigator: |
Daniel J George, MD |
Duke University Health System |
|
|
| Duke University |
| September 2009 |