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A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer


Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.


Inclusion Criteria:



- Confirmed adenocarcinomas of the prostate.

- Evidence of metastatic disease

- Evidence of disease progression including one of the following: increasing levels of
PSA, progressive lymph node disease, or worsening bone scan

- PSA level is greater or equal to 7 ng/ml.

- ECOG performance status less than or equal to 1

Exclusion Criteria :

- Previously received bicalutamide, flutamide, or nilutamide within the past 12 months
(except for a period of use less than 30 days long).

- Prior chemotherapy for prostate cancer

- Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or
temsirolimus.

- Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer

- Patient has pain related to prostate cancer that warrants the initiation of
chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

30% Prostate specific antigen (PSA) decline within 12 weeks

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_572

NCT ID:

NCT00777959

Start Date:

December 2008

Completion Date:

May 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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