title: Strategy and planning for chemopreventive drug development: clinical development plans II.
abstract: This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole-3-carbinol, perillyl alcohol, phenethyl isothiocyanate, 9-cis-retinoic acid, 13-cis-retinoic acid, l-selenomethionine and 1, 4-phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)-vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs.
authors.affiliation: Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892, USA.
authors.forename: G J
authors.initials: GJ
authors.lastname: Kelloff
authors.forename: J A
authors.initials: JA
authors.lastname: Crowell
authors.forename: E T
authors.initials: ET
authors.lastname: Hawk
authors.forename: V E
authors.initials: VE
authors.lastname: Steele
authors.forename: R A
authors.initials: RA
authors.lastname: Lubet
authors.forename: C W
authors.initials: CW
authors.lastname: Boone
authors.forename: J M
authors.initials: JM
authors.lastname: Covey
authors.forename: L A
authors.initials: LA
authors.lastname: Doody
authors.forename: G S
authors.initials: GS
authors.lastname: Omenn
authors.forename: P
authors.initials: P
authors.lastname: Greenwald
authors.forename: W K
authors.initials: WK
authors.lastname: Hong
authors.forename: D R
authors.initials: DR
authors.lastname: Parkinson
authors.forename: D
authors.initials: D
authors.lastname: Bagheri
authors.forename: G T
authors.initials: GT
authors.lastname: Baxter
authors.forename: M
authors.initials: M
authors.lastname: Blunden
authors.forename: M K
authors.initials: MK
authors.lastname: Doeltz
authors.forename: K M
authors.initials: KM
authors.lastname: Eisenhauer
authors.forename: K
authors.initials: K
authors.lastname: Johnson
authors.forename: G G
authors.initials: GG
authors.lastname: Knapp
authors.forename: D G
authors.initials: DG
authors.lastname: Longfellow
authors.forename: W F
authors.initials: WF
authors.lastname: Malone
authors.forename: S G
authors.initials: SG
authors.lastname: Nayfield
authors.forename: H E
authors.initials: HE
authors.lastname: Seifried
authors.forename: L M
authors.initials: LM
authors.lastname: Swall
authors.forename: C C
authors.initials: CC
authors.lastname: Sigman
mesh_terms: D000818:Animals; D016588:Anticarcinogenic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002471:Cell Transformation, Neoplastic; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D004354:Drug Screening Assays, Antitumor / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000517:prevention & control*; D009374:Neoplasms, Experimental / Q000517:prevention & control
chemical_list: D016588:Anticarcinogenic Agents