Phase II cancer prevention clinical trials.
The development of agents to prevent cancer requires an iterative process of target identification, preclinical testing, and early and late phase clinical trials to establish efficacy and safety. Since phase III definitive efficacy trials with cancer endpoints require a lengthy timeframe and considerable resources for completion, it is critical to first optimize agent delivery and trial design and to determine preliminary efficacy via the conduct of phase II trials. Phase II trials vary considerably in their endpoints, cohorts, and designs due to differences in the process of carcinogenesis and ability to sample tissues across different target organs. However, the goal of all such trials is to provide evidence of interference with the development of cancer and to identify safety signals that would limit the benefit from interventions.
Szabo
Eva
E
Lung and Upper Aerodigestive Cancer Research Group, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. szaboe@mail.nih.gov
D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D009369:Neoplasms / Q000473:pathology / Q000517:prevention & control*
Mol Cancer Ther. 2008 Apr;7(4):972-9
18375820
J Natl Cancer Inst. 2003 Mar 19;95(6):470-8
12644540
Nat Rev Cancer. 2002 Jan;2(1):19-27
11902582
Clin Cancer Res. 2003 Jan;9(1 Pt 2):502S-10S
12538507
Chest. 2000 Jun;117(6):1572-6
10858385
J Natl Cancer Inst. 1990 Apr 4;82(7):555-60
2179569
Sci Transl Med. 2010 Apr 7;2(26):26ra25
20375364
Cancer Invest. 2008 Feb;26(1):1-10
18181038
JAMA. 2006 Jun 21;295(23):2727-41
16754727
Lancet. 2009 Jul 25;374(9686):301-14
19586656
Eur J Cancer. 2003 Apr;39(6):793-9
12651205
Clin Cancer Res. 2002 Feb;8(2):314-46
11839647
N Engl J Med. 2007 May 10;356(19):1928-43
17494926
J Natl Cancer Inst. 1989 Dec 20;81(24):1879-86
2593165
Cancer Prev Res (Phila). 2010 Feb;3(2):128-31
20103726
Clin Cancer Res. 2002 Oct;8(10):3105-17
12374678
J Natl Cancer Inst. 2002 Jul 3;94(13):1001-9
12096085
N Engl J Med. 2010 Mar 18;362(11):986-93
20237344
J Natl Cancer Inst. 2007 May 2;99(9):715-26
17470739
J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88
9747868
Nat Rev Cancer. 2006 Nov;6(11):867-74
17036038
Clin Cancer Res. 2006 Jun 15;12(12):3661-97
16778094
Breast Cancer Res Treat. 2007 Nov;106(1):75-84
17221152
Clin Cancer Res. 2005 Jan 1;11(1):12-9
15671523
Cancer Prev Res (Phila). 2008 Jun;1(1):32-8
18841250
Am J Respir Crit Care Med. 2001 Nov 1;164(9):1688-93
11719311
Nature. 2008 Oct 23;455(7216):1069-75
18948947
Cancer Prev Res (Phila). 2010 Feb;3(2):148-59
20103722
Gastroenterology. 2006 Dec;131(6):1674-82
17087947
Cancer. 1984 Feb 1;53(3):563-8
6537892
BMJ. 2000 Aug 5;321(7257):323-9
10926586
N Engl J Med. 1996 May 2;334(18):1150-5
8602180
Ann Oncol. 2005 Nov;16(11):1811-6
16087693
Clin Cancer Res. 2004 Oct 1;10(19):6502-11
15475437
N Engl J Med. 1994 Apr 14;330(15):1029-35
8127329
Nat Rev Drug Discov. 2009 Mar;8(3):213-25
19247304
J Natl Cancer Inst. 2007 Apr 4;99(7):545-57
17405999
Cancer Epidemiol Biomarkers Prev. 2006 Jul;15(7):1382-91
16835340
Cancer Invest. 2005;23(3):274-80
15945512
Cell. 2000 Jan 7;100(1):57-70
10647931
N Engl J Med. 2000 Jun 29;342(26):1946-52
10874062
Clin Cancer Res. 2000 Feb;6(2):357-62
10690511
N Engl J Med. 2005 Mar 17;352(11):1092-102
15713943