Description
Few adult malignancies are cured with currently available therapies means that cancer drug development remains an important area of unmet need in clinical research. Given the mechanism of action and potential side effects of the drugs which treat cancers Phase I studies in oncology are unusual in that dose finding studies are performed in patients with incurable disease, rather than healthy volunteer studies being the norm.
Additionally the recent advances in the understanding of the molecular biology of tumours has meant that targeted cancer treatments and stratified medicine are becoming a reality, but this molecular profiling presents its own challenges in early clinical drug development. These factors have led to study designs and end points which are specific to the area of oncology clinical research. Phase I study design with the methodologies used to reduce risks of treatment but also minimize patient numbers will be discussed. The seminar will also explore the end points of studies whether toxicity driven or biomarker driven and the potential role of the phase 0 study in oncology drug development.
Learning Objectives
At the end of the webinar, learners will be able to:
• Outline the commonly used phase I oncology trial designs and the potential benefits and pitfalls of the approaches.
• Be aware of trial endpoints and the information gained from these
• Have an awareness of the ethical implications of exploratory studies in cancer patients
• Outline phase 0 study dosing and its use in oncology
• Describe newly trials designs suitable for molecularly targeted agents
The Expert
Ruth Plummer is Professor of Experimental Cancer Medicine at the Northern Institute for Cancer Research, Newcastle University and an honorary consultant medical oncologist in Newcastle Hospitals Foundation Trust. She is also Director of the Sir Bobby Robson Cancer Trials Research Centre within the Northern Centre for Cancer Care which is a dedicated clinical trials unit based within the regional cancer centre. She trained at Cambridge and Oxford before moving back home to Newcastle and settling with her family in the Tyne valley.
Her research interests are in the field of DNA repair and early phase clinical trials of novel agents or novel imaging targets. This work is either based on the Sir Bobby Robson Cancer Trials Research Centre at the Northern Centre for Cancer Care or within the Clinical and Translational Research Group in the Northern Institute for Cancer Research which she leads. Nationally she sits on the NCRN Melanoma study group and also the CTRad executive group, co-chairing the work stream developing novel radiotherapy combination trials.
