Evaluation of tumor size response metrics to predict survival in oncology clinical trials

R Bruno, F Mercier, L Claret - Clinical Pharmacology & …, 2014 - Wiley Online Library
Model‐based drug development in oncology is still lagging despite a good momentum in the
clinical pharmacology and pharmacometry community in the past few years. The failure rate …

[HTML][HTML] Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND …

H Piessevaux, M Buyse, W De Roock, H Prenen… - Annals of oncology, 2009 - Elsevier
Background Early radiological tumor shrinkage may be associated with better long-term
outcome in chemorefractory metastatic colorectal cancer (cmCRC) treated with cetuximab …

Clinical trials in the era of personalized oncology

ML Maitland, RL Schilsky - CA: a cancer journal for clinicians, 2011 - Wiley Online Library
The rapid pace of discoveries in tumor biology, imaging technology, and human genetics
hold promise for an era of personalized oncology care. The successful development of a …

Monitoring predominantly cytostatic treatment response with 18F-FDG PET

KB Contractor, EO Aboagye - Journal of Nuclear Medicine, 2009 - Soc Nuclear Med
18 F-FDG PET and, more recently, PET/CT have been established as response biomarkers
for monitoring cytotoxic or cytoreductive cancer therapies. With the advent of targeted cancer …

Early changes in tumor size in patients treated for advanced stage nonsmall cell lung cancer do not correlate with survival

KR Birchard, JK Hoang, JE Herndon Jr, EF Patz Jr - Cancer, 2009 - Wiley Online Library
BACKGROUND: In clinical trials, change in tumor size is used to stratify patients into
response categories. The objective of the current study was to: 1) determine whether early …

[HTML][HTML] Early tumour shrinkage as a prognostic factor and surrogate end-point in colorectal cancer: a systematic review and pooled-analysis

F Petrelli, F Pietrantonio, C Cremolini… - European Journal of …, 2015 - Elsevier
Purpose Early tumour shrinkage (ETS), defined as a reduction of at least 20% in tumour size
at first reassessment, has been recently investigated retrospectively in first-line trials of …

Alternate endpoints for screening phase II studies

N Dhani, D Tu, DJ Sargent, L Seymour… - Clinical Cancer Research, 2009 - AACR
Phase II trials are screening trials that seek to identify agents with sufficient activity to
continue development and those for which further evaluation should be halted. Although …

Novel designs and end points for phase II clinical trials

AA Adjei, M Christian, P Ivy - Clinical Cancer Research, 2009 - AACR
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 …

Optimal dose‐finding designs with correlated continuous and discrete responses

V Fedorov, Y Wu, R Zhang - Statistics in medicine, 2012 - Wiley Online Library
In dose‐finding clinical studies, it is common that multiple endpoints are of interest. For
instance, in phase I/II studies, efficacy and toxicity are often the primary endpoints, which are …

A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer

DJ Renouf, MJ Moore, D Hedley, S Gill, D Jonker… - Investigational new …, 2012 - Springer
Summary Aim This phase I/II study of saracatinib in combination with gemcitabine in patients
with advanced pancreatic cancer was conducted by the NCIC Clinical Trials Group. The …