- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629525
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Clinical or radiographic evidence of metastatic disease
- ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However, ketoconazole, estrogens, and all other forms of hormonal manipulation are not permitted on study.
Evidence of disease progression on ADT as evidenced by:
- 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, or
- Radiographic evidence of disease progression defined by RECIST criteria and compared to prior studies on ADT.
- A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal response.
- A minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent
- Biopsies will not be performed if platelet counts < 75,000/ ul, PTT, PT or INR > 1.4 times control
- Patients must have normal organ and marrow function as defined below:
- hemoglobin > 9.0g/dL
- absolute neutrophil count > 1,500/μl
- platelets > 100,000/μl
- total bilirubin < 1.5 X upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) < 2.5 X ULN
- creatinine < 1.5 X ULN
- total fasting cholesterol < 350
- total triglycerides < 300
- Patients on antilipid therapy may participate in this study.
- Age > 18 years
- ECOG performance status 0 or 1
- Ability to swallow and retain oral medication
- Ability to understand and the willingness to sign a written informed consent document.
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RAD001
RAD001 at a dose of 10 mg PO daily
|
RAD001 at a dose of 10 mg PO daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical Response Rate
Time Frame: Patients were followed for a median of 315 days
|
Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
|
Patients were followed for a median of 315 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Response
Time Frame: Patients were followed for a median of 315 days
|
Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index
|
Patients were followed for a median of 315 days
|
Progression Free Survival
Time Frame: Patients were followed for a median of 315 days, with the last patient censored at 1309 days.
|
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.
|
Patients were followed for a median of 315 days, with the last patient censored at 1309 days.
|
Molecular Response
Time Frame: Patients were followed for a median of 315 days
|
Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.
|
Patients were followed for a median of 315 days
|
Clinical Response
Time Frame: Patients were followed for a median of 315 days
|
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 |
Patients were followed for a median of 315 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel J George, MD, Duke Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00009495
- 7521 (Other Identifier: Duke legacy protocol ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hormone Refractory Prostate Cancer
-
University of California, IrvineBristol-Myers SquibbCompletedRecurrent Prostate Cancer | Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Hormone-refractory Prostate CancerUnited States
-
DendreonCompletedHormone Refractory Prostate Cancer | Castration-resistant Prostate Cancer | Prostate Cancer MetastaticUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownHormone Refractory Prostate Cancer | Metastatic Prostate CarcinomaChina
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Hormone-refractory Prostate CancerUnited States
-
PfizerAstellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.CompletedProstate Cancer | Hormone Refractory Prostate CancerUnited States
-
Spanish Oncology Genito-Urinary GroupAstellas Pharma Inc; Apices Soluciones S.L.CompletedHormone-refractory Prostate CancerSpain
-
Peking UniversityWithdrawnHormone Refractory Prostate CancerChina
-
Tianjin Medical University Cancer Institute and...UnknownHormone Refractory Prostate CancerChina
-
CytoVac A/SCompletedHormone-refractory Prostate CancerDenmark
-
British Columbia Cancer AgencyCompletedHormone Refractory Prostate CancerCanada
Clinical Trials on RAD001
-
Children's Hospital Medical Center, CincinnatiNovartisCompletedTuberous Sclerosis | AngiolipomaUnited States
-
Novartis PharmaceuticalsCompletedMetastatic Renal Cell Carcinoma (mRCC)Germany
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Children's Hospital of Philadelphia; Washington... and other collaboratorsCompleted
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompletedLymphangioleiomyomatosis (LAM) | Tuberous Sclerosis Complex (TSC)United States, United Kingdom, Germany, Italy, Russian Federation, Netherlands, Japan, Canada, Poland, France, Spain
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedBrain and Central Nervous System TumorsUnited States, Israel, Canada
-
University of ChicagoNovartis PharmaceuticalsTerminatedNon-Small Cell Lung CancerUnited States
-
Guangdong Provincial People's HospitalNovartisUnknownNeuroendocrine Tumors | Carcinoid TumorChina
-
Fox Chase Cancer CenterRecruitingMetastatic Pancreatic CancerUnited States
-
Novartis PharmaceuticalsTerminatedHepatocellular CarcinomaUnited States, Spain, Korea, Republic of, Netherlands, Taiwan