NCT01981551 - 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)

de Bree E, Keus R, Melissas J, Tsiftsis D, van Coevorden F
Desmoid tumors: need for an individualized approach. Expert Rev Anticancer Ther. 2009 Apr;9(4):525-35. doi: 10.1586/era.09.9.
Kummar S, O'Sullivan Coyne G, Do KT, Turkbey B, Meltzer PS, Polley E, Choyke PL, Meehan R, Vilimas R, Horneffer Y, Juwara L, Lih A, Choudhary A, Mitchell SA, Helman LJ, Doroshow JH, Chen AP
Clinical Activity of the gamma-Secretase Inhibitor PF-03084014 i
Lev D, Kotilingam D, Wei C, Ballo MT, Zagars GK, Pisters PW, Lazar AA, Patel SR, Benjamin RS, Pollock RE
Optimizing treatment of desmoid tumors. J Clin Oncol. 2007 May 1;25(13):1785-91. doi: 10.1200/JCO.2006.10.5015.
Lewis JJ, Boland PJ, Leung DH, Woodruff JM, Brennan MF
The enigma of desmoid tumors. Ann Surg. 1999 Jun;229(6):866-72; discussion 872-3. doi: 10.1097/00000658-199906000-00014.

Phase II Trial of the Gamma-Secretase Inhibitor PF-03084014 in Adults With Desmoid Tumors/Aggressive Fibromatosis

Clinical trial NCT01981551 - References