Multiple Histology Phase II Trials

Multiple Histology Phase II Trials.

PURPOSE Testing agents in cancers with multiple disease subtypes, in which the activity of a new treatment may vary between subtypes, presents statistical and logistical challenges. We propose a flexible phase II strategy which includes both analyses for each histology or stratum and a combined analysis which borrows information from all the patients in the study. Sequential futility analyses a...

Design issues of randomized phase II trials and a proposal for phase II screening trials.

Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II trials have been key components in the prioritization process. There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm to provide greater ass...

Phase II oncology trials: let's be positive.

The critical decision in drug development is often at the end of phase II, as phase III trials are an expensive undertaking, with the potential for significant corporate and public consequences in the event of a negative phase III trial. Thus, retrospective analyses of the usefulness of phase II trials are welcomed and valued, as illustrated by the study of Goffin et al. (1). In this analysis o...

Adaptive designs for Phase II oncology trials

The role of Phase II trials in oncology drug development Traditionally, Phase II in oncology drug development acts as a screening tool by identifying treatments with sufficient activity that warrant further investigation in large and costly Phase III studies. However, Phase II has also another more prominent role in cancer research as there is a significant number of drugs that were approved ba...

Arthritis gene therapy trials reach phase II.