UCL CANCER INSTITUTE. The UCLH / UCL Cancer Clinical Research Facility

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1 UCL CANCER INSTITUTE The UCLH / UCL Cancer Clinical Research Facility

2 The UCLH / UCL Cancer Clinical Research Facility (CCRF) The CCRF is a state-of-the-art facility for cancer drug development. Located on the ground floor of the new University College Hospital, the unit provides twenty treatment spaces, clinic rooms, a pharmacy dispensary and a GCLP sample handling laboratory. A broad portfolio of academic and commercially sponsored early phase clinical trials are undertaken, including first in man as well as tumour specific phase I and II trials. The unit is located within a multidisciplinary hospital with ready access to emergency facilities and intensive care. The UCL Cancer Institute, the new Cancer Centre and the main UCL Campus are all within a few minutes walk providing an outstanding environment for Experimental Cancer Medicine. The CCRF is located on the ground floor of UCLH in Central London Support and Funding Funding to develop the unit was provided by the National Institute for Health Research (NIHR), Wellcome Trust, Wolfson Foundation and Cancer Institute Research Trust. Additionally, Cancer Research UK and the NIHR provide key infrastructure via the UCL Experimental Cancer Medicine Centre and UCLH/UCL Biomedical Research Unit. Sarah Cannon Research UK An important partnership has been established with the Sarah Cannon Research Institute and the newly established Early Phase Trials Unit in Harley Street directed by Dr Tobi Arkenau. This collaboration increases the access for our patients to the latest novel anti-cancer agents though a joint portfolio and establishes a research partnership focussed on personalising cancer therapy.

3 Links with the UCL Cancer Institute The UCL Cancer Institute opened in 2007 representing a 50M investment and housing over 350 scientific staff. Particular areas of expertise include epigenetics and genomics, gene and cellular therapy, stem cells, signal transduction and transcription factors,viral oncology and targeted therapies. The main GCLP lab is also located in the Cancer Institute. The GCLP Facility contains a large assay lab for pharmacokinetic (PK) and pharmacodynamic studies, a lab for handling radioactive trial samples, a separate PCR lab, a monitored sample storage area, a microscope room and a clinical sample-handling lab which is linked to the Clinical Research Facility. PK studies are undertaken using primarily HPLC (UV and fluorescence) and LC-MS/MS. A wide range of pharmacodynamic studies are validated and performed with a particular expertise in circulating tumour cells, Comet and DNA damage response foci, PCR and ELISA-based assays. The Cancer Institute is next to the CCRF and houses the GCLP laboratory Circulating tumour cells from patients can be used to provide important prognositic information and are being developed as biomarkers for drug development.

4 Imaging Extensive CT and MR Imaging facilities are available at UCLH. Additionally, there are two PET scanners, a dedicated research SPECT/CT scanner and a PET/MRI will be installed in the new Cancer Centre in A dedicated Phase I radiologist provides a reporting service, supporting the Phase I multidisciplinary team. The newly installed research SPECT/CT will support trials of radio-targeted therapy and molecular imaging. Illustrated is an example from a recently completed trial using 131I- L19-SIP which is a radiolabelled small immunopeptide that targets the extra-domain B of fibronectin expressed in tumour vasculature. The immunoconjugate is selectively taken up in the neck tumour with a high tumour to background ratio at 48 hours.

5 Recently completed trials Examples of innovative trials include those that are first in man such as the novel HDAC inhibitor JNJ Over 20 patients with a variety of solid tumours were recruited. The results will be presented at the forthcoming AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in San Francisco. Having defined the maximum tolerated dose, this drug will be taken forward in malignant myeloma in combination with bortezomib. Other trials focus on specific tumour types such as the recently completed Phase I trial of BIBF1120 for hepatocellular carcinoma. The results, which were presented recently at the International Liver Cancer Association conference in Hong Kong, showed that the drug had encouraging activity. A randomised phase II has just opened comparing BIBF1120 with sorafenib, the current standard of care. Baseline 3 months post treatment Response to BIBF1120 in a patient with hepatocellular with reduction in size of para-caval lymph node. How to Refer a Patient for Phase I Assessment phase1cancer@uclh.nhs.uk Post: Kerry Guile, Lead Nurse, Clinical Research Facility, EGA Wing, UCH, 235 Euston Road London NW1 2BU Tel: ext 76046

6 Staff Director of Cancer CRF Tim Meyer... Director of Drug Development Hilary Calvert... Director GCLP Laboratory John Hartley... Director of Drug Development Sarah Cannon Research UK Tobi Arkenau... Director of Cancer Research UK and UCL Cancer Trials Centre Jonathan Ledermann... Consultants Rebecca Kristeleit... Martin Forster... Research Nurses Lead Nurse Kerry Guile... Edwina Saunders Nicola Macfarlane Marivic Ricamara Anne Jennings Maria Piga Louise Cusack Claire Jarvis Clinical Trial Coordinator Alan Sahin Portfolio Manager David Collin Pharmacy Clinical Trials Lead Rita Gupta Clinical Fellow Duncan Wilkins Roberta Granata Robert Goldstein Technicians Natalie Griffin Helen Lowe Janet Hartley Theodora Tsigani Yashma Patel Claire Green Christopher Allen Sarah Jenkinson

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