The article discusses the Phase 0 clinical trials for anticancer drug development. Expert in the field, James Doroshow says that Phase 0 trials allow the rapid determination of proof of mechanism in human tumours. The guidelines for Phase 0 trials, issued by the U.S. Food and Drug ...
t Phase 0 Trial.]]>doi:10.1093/jnci/djp213The article offers information on the results of the first phase 0 trial of a cancer drug published by the National Cancer Institute. It cites an experiment that checks whether a new drug known as ABT-888 can hit two deoxyribonucleic acid (DNA)...
In addition, they rightfully address a number of key questions including whether the p hase 0 study will improve the efficacy of subsequent trials, whether patients will take part in a trial that is of no benefit to them and whether phase 0 trials are needed to demonstrate pharmacodynamic (PD...
et al. First-in-human phase 0 trial of oral 5-iodo-2-pyrimidinone-2’-deoxyribose in patients with advanced malignancies. Clin. Cancer Res. 19, 1852–1857 (2013). CAS PubMed PubMed Central Google Scholar Carpenter, A. P. Jr., Pontecorvo, M. J., Hefti, F. F. & Skovronsky, D....
The observed survival differences support further exploration in an adequately powered randomised controlled trial. Clinical trial registration ClinicalTrials.gov: Part 1– NCT01812603; Part 2– NCT01812616.Similar content being viewed by others A phase II study of the safety of olanzapine for ...
The primary aim of such a trial will be to test the hypothesis that disease-free survival and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy. The secondary aim of the trial will be to determine the safety of of laparoscopic-assisted...
A randomized clinical trial of cis-platin/paclitaxel versus carboplatin/paclitaxel ... Despite considerable improvement in the treatment of advanced ovarian cancer, the optimization of efficacy and tolerability remains an important issue. The... DU BOIS,A - 《J Natl Cancer Inst》 被引量: 100发表...
0 32 1 68 Prior radiation therapy (%) 31 NSCLC, non-small cell lung cancer; ECOG, Eastern Cooperative Oncology Group. Treatment Of the 85 patients entered on trial, 81 received at least one dose of study drug and were included in the primary analysis. Four patients never received ...