Warning: Undefined variable $zfal in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 525
Deprecated: str_replace(): Passing null to parameter #3 ($subject) of type array|string is deprecated in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 525
Warning: Undefined variable $sterm in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 530
Warning: Undefined variable $sterm in C:\Inetpub\vhosts\kidney.de\httpdocs\mlpefetch.php on line 531
English Wikipedia
Nephropedia Template TP (
Twit Text
DeepDyve Pubget Overpricing |
lüll Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice Kinders R; Parchment RE; Ji J; Kummar S; Murgo AJ; Gutierrez M; Collins J; Rubinstein L; Pickeral O; Steinberg SM; Yang S; Hollingshead M; Chen A; Helman L; Wiltrout R; Simpson M; Tomaszewski JE; Doroshow JHMol Interv 2007[Dec]; 7 (6): 325-34The Food and Drug Administration (FDA) recently introduced the Exploratory Investigational New Drug Guidance to expedite the clinical evaluation of new therapeutic and imaging agents. Early clinical studies performed under the auspices of this guidance, so-called "Phase 0" trials, have been initiated at the National Cancer Institute to integrate qualified pharmacodynamic biomarker assays into first-in-human cancer clinical trials of molecularly targeted agents. The goal of this integration is to perform molecular proof-of-concept investigations at the earliest stage of cancer drug development. Phase 0 trials do not offer any possibility of patient benefit; instead, intensive, real-time pharmacodynamic and pharmacokinetic analyses of patient tumor samples and/or surrogate tissues are performed to inform subsequent trials. Phase 0 studies do not replace formal Phase I drug safety testing and require a substantial investment of resources in assay development early on; however, they offer the promise of more rational selection of agents for further, large-scale development as well as the molecular identification of potential therapeutic failures early in the development process.|*Antineoplastic Agents/pharmacokinetics/pharmacology[MESH]|*Drugs, Investigational/pharmacokinetics/pharmacology[MESH]|Clinical Trials as Topic/ethics/*methods[MESH]|Drug Design[MESH]|Humans[MESH]|Neoplasms/drug therapy[MESH]|United States[MESH]|United States Food and Drug Administration[MESH] |