Ongoing Clinical Trials / Prostrate Cancer - Deforolimus
Trial Information
Prostrate Cancer: Clinical Trial of Deforolimus for men with metastatic disease.
- Principal Investigator: Matthew Rettig, M.D.
- Co-Investigators: Jean deKernion, M.D., Robert Reiter, M.D
This trial is currently accepting new patient applications
Objective
A study comparing treatment of metastatic disease with a combination of Deforolimus and Bicalutamide versus Bicalutamide alone.
The purpose of this study is to test the efficacy and safety of the research study drug, Deforolimus (also known as MK-8669), and to see if Deforolimus with Bicalutamide (CASODEX™) works better than Bicalutamide alone in the treatment of prostate cancer.
Deforolimus is a small-molecule inhibitor of the protein mTOR, a “master switch” in cancer cells. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism, and angiogenesis.
Trial Design
Randomized, Double-Blind, Placebo Controlled Phase 2 Study
You will be assigned by chance to one of two groups: the experimental group where you will receive deforolimus (MK-8669) or the placebo control group where you will receive a placebo (inactive ingredient with no effect). You will have a 1 in 2 chance (50%) of getting deforolimus . Neither you nor the study doctor will know which of these you are receiving. However, in the event of an emergency, the intervention can be revealed.
Groups
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Intervention
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1: Experimental
Deforolimus
+ bicalutamide
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Drug: Deforolimus (MK8669)
Four 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without deforolimus.
One 50 mg tablet of bicalutamide administered once daily for 7 days each week.
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2:Placebo Control
Placebo
+ bicalutamide
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Drug: Placebo
Four tablets of matching placebo to deforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo
One 50 mg tablet of bicalutamide administered once daily for 7 days each week.
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Patient Eligibility
Inclusion Criteria:
- Confirmed adenocarcinoma 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 while on hormone therapy (or after surgical castration)
- PSA level is greater or equal to 10 ng/ml
Exclusion Criteria:
- Previously received bicalutamide, flutamide, or nilutamide within the past 12 months
- Prior chemotherapy for prostate cancer
- Prior rapamycin or rapamycin analogs, including deforolimus, everolimus, or temsirolimus
- Patient has pain related to prostate cancer that warrants the initiation of chemotherapy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
For more information
For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call recruitment coordinator Diana Sarkisyan at (310) 206-7793 (dsarkisyan@mednet.ucla.edu) or Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.
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