Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience.

ABSTRACT: The main aim of phase I trials is to evaluate the tolerability and pharmacology of a new compound. However, investigating the potential for clinical benefit is also a key objective. Our phase I trial portfolio incorporates a range of new drugs, including molecular targeted agents, sometimes given together with cytotoxic agents. We performed this analysis of response rate, progression-free (PFS) and overall survival (OS) to assess the extent of clinical benefit rate (CBR: partial response (PR)+stable disease (SD)) derived from current trials. We analysed 212 consecutive patients who were treated in 29 phase I studies, from January 2005 to June 2006. All patients had progression of disease prior to study entry. The median age was 58 years (range: 18-86) with a male/female ratio of 2 : 1. A t

SUBMITTER: Arkenau HT 

PROVIDER: S-EPMC2275488 | biostudies-literature | 2008 Mar

REPOSITORIES: biostudies-literature