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An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Last updated on November 21, 2019

FOR MORE INFORMATION
Study Location
Houston, Texas, 77030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a
minimum of 6 core biopsy samples.

- Subjects must be a candidate for radical prostatectomy

- No evidence of metastatic disease as determined by CT scans and bone scans

- More criteria apply

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects from whom sufficient diagnostic biopsy material is not available for full
characterization of the tumor

- Active Infection requiring antibiotic therapy, or serious intercurrent illness, active
bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical
resection

- Subjects who have had hormonal injection or implants which will last longer than 6
months

- More criteria apply

NCT00235794
Pfizer
Completed
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
Official Title  ICMJE An Open Label Study of Exploratory Pharmacogenomics and Pharmacologic Effects of Neoadjuvant Oral Temsirolimus in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have a High Risk of Relapse
Brief SummaryOpen-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: temsirolimus
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 8, 2007)
50
Original Enrollment  ICMJE
 (submitted: October 6, 2005)
10
Actual Study Completion Date  ICMJE September 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a minimum of 6 core biopsy samples.
  • Subjects must be a candidate for radical prostatectomy
  • No evidence of metastatic disease as determined by CT scans and bone scans

    • More criteria apply

Exclusion Criteria:

  • Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor
  • Active Infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection
  • Subjects who have had hormonal injection or implants which will last longer than 6 months

    • More criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00235794
Other Study ID Numbers  ICMJE 3066A1-132
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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