RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

NCT00629525 | Completed Phase 2 Results

• 2 other identifiers: Pro000094957521
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical Response Rate

  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 Outcomes (4)

• Pathologic Response

  Patients were followed for a median of 315 days

• Progression Free Survival

  Patients were followed for a median of 315 days, with the last patient censored at 1309 days.

• Molecular Response

  Patients were followed for a median of 315 days

• Clinical Response

  Patients were followed for a median of 315 days

Study Arms (1)

RAD001

EXPERIMENTAL

RAD001 at a dose of 10 mg PO daily

Drug: RAD001

Interventions

RAD001 DRUG

RAD001 at a dose of 10 mg PO daily

Also known as: Everolimus

RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel George, MD: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Duke University MEdical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Daniel George
• Organization: Duke University

daniel.george@duke.edu

919-668-4615

Study Officials

• Daniel J George, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: August 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 3, 2015
• Results First Posted: February 7, 2013

Record last verified: 2015-02

Locations

US (1)