Phase 0 trial as first human study in translational research in medical technology

Tumori

Volumn 94, Issue 4, 2008, Pages 626-627

  Zanon, Claudio ^a  

^a MOLINETTE HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ABT 888; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE INHIBITOR; UNCLASSIFIED DRUG;

BREAST CANCER; CANCER SCREENING; CANCER SIZE; CLINICAL STUDY; CLINICAL TRIAL; COLONOSCOPY; COMPUTER ASSISTED TOMOGRAPHY; DNA DAMAGE; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; ECHOMAMMOGRAPHY; FEASIBILITY STUDY; GASTROSCOPY; HUMAN; LETTER; LIVER CANCER; LUNG CANCER; MEDICAL INFORMATION; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; NONHUMAN; RADIOFREQUENCY ABLATION; SENSITIVITY AND SPECIFICITY; SINGLE DRUG DOSE; SOLID TUMOR; THERMOGRAPHY; TREATMENT RESPONSE;

EID: 54749129894     PISSN: 03008916     EISSN: None     Source Type: Journal    
DOI: 10.1177/030089160809400437     Document Type: Letter

References (6)

1. Kummar S, Kinders R, Gutierrez M, Rubinstein L, Parchment RE, Phillips LR, Low J, Murgo AJ, Tomaszewski JE, Doroshow JH, NCI Phase 0 Working Group: Inhibition of poly (ADP ribose) polymerase (PARP) by ABT-888 in patients with advanced malignancies: Results of a phase 0 trial. J Clin Oncol, 2007 ASCO Annual Meeting Proc, 18S: abstr 3518, 2007.
2. Willis RC: What is phase zero? Scientist, 19: 38, 2005.
3. von Eschenbach AC: New FDA guidance aims to speed early drug development. NCI Cancer Bulletin, 3(3): 1-2, 2006.
4. New approaches to cancer drug development and clinical trials: questions and answers. Website of the National Cancer Institute Available at http://www.cancer.gov/newscenter/pressreleases/PhaseZeroNExTQandA/print?page= &keyword=. Accessed 18 June, 2008.
5. Hill TP: Phase 0 trials: are they ethically challenged? Clin Cancer Res, 13: 783-784, 2007.
6. Marchetti S, Schellens JH: The impact of FDA and EMEA guidelines on drug development in relation to phase 0 trials. Br J Cancer, 97: 577-581, 2007.