Given the multitude of novel anticancer drugs and the limited resources available to study
them, phase II trials should identify drugs with the highest probability of succeeding in …

In cancer research, a traditional phase II trial is designed as a single-arm trial that compares
the experimental therapy to a historical control. This simple trial design has led to several …

Phase II trials are used to show sufficient preliminary activity of a new treatment (in single-
arm designs or randomized screening designs) or to select among treatments with …

Although the Code of Federal Regulations (21 CFR 312.21) defines phase II studies as
''controlled clinical studies,''the vast majority of phase II oncology trials have been single-arm …

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 …

Phase II trials remain a critical step in drug development. They are conducted “to evaluate
the effectiveness of a drug for a particular tumor type and to further determine the common …

Life for the clinical investigator was much simpler 30 years ago. With only a handful of
available cytotoxic agents, often obtained from cell line screens of plant-derived extracts, the …

Historically, phase II oncology trials assessed a treatment's efficacy by examining its tumor
response rate in a single-arm trial. Then, approximately 25 years ago, certain statistical and …

The traditional oncology drug development paradigm of single arm phase II studies followed
by a randomized phase III study has limitations for modern oncology drug development …

The large number of negative phase III trials in oncology over the last several years has
renewed interest in refining phase II oncology clinical trials to maximize the chances of …