[Guideline for phase I study on new anticancer agents].

Abstract

Since more than 50% of patients with cancer could no be cured by present standard therapy, new effective anticancer agents are needed in clinical level. In the evaluation of new anti-cancer agents by phase I study, there are several important and specific issues from scientific, medical, statistical, and ethical view points. Clinical safety data management is critically important in phase I study. This paper shows major parts of a report entitled "Guideline for phase I study on new anticancer agents", already published in JPs Pharmacol Ther 26: 441-454, 1998, with minor modification in order to answer these issues.

• Authors: M Shimoyama
• Journal: Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 28 Issue 2 Pg. 261-70 (Feb 2001) ISSN: 0385-0684 [Print] Japan
• PMID: 11242659 (Publication Type: English Abstract, Journal Article)

Chemical References

• Antineoplastic Agents

Topics

• Antineoplastic Agents (therapeutic use)
• Clinical Trials, Phase I as Topic (standards)
• Humans
• Neoplasms (drug therapy)