NCT00596011 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kim SJ, Amankwah E, Connors S, Park HY, Rincon M, Cornnell H, Chornokur G, Hashim AI, Choi J, Tsai YY, Engelman RW, Kumar N, Park JY
Safety and chemopreventive effect of Polyphenon E in preventing early and metastatic progression of prostate cancer in TRAMP mice. Cancer Prev Res (Phila). 2014 Apr;7(4):435-44. doi: 10.1158/1940-6207.CAPR-13-0427-T. Epub 2014 Feb 5.
Kumar NB, Patel R, Pow-Sang J, Spiess PE, Salup R, Williams CR, Schell MJ
Long-term supplementation of decaffeinated green tea extract does not modify body weight or abdominal obesity in a randomized trial of men at high risk for prostate cancer. Oncotar
Kumar NB, Pow-Sang J, Spiess PE, Park J, Salup R, Williams CR, Parnes H, Schell MJ
Randomized, placebo-controlled trial evaluating the safety of one-year administration of green tea catechins. Oncotarget. 2016 Oct 25;7(43):70794-70802. doi: 10.18632/onco
Kumar NB, Pow-Sang JM, Spiess PE, Park JY, Chornokur G, Leone AR, Phelan CM
Chemoprevention in African American Men With Prostate Cancer. Cancer Control. 2016 Oct;23(4):415-423.

Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia (HGPIN) or Atypical Small Acinar Proliferation (ASAP)

Details for clinical trial NCT00596011

Clinical trial NCT00596011 - References