Phase 1 Trials
Clinical drug development
Cancer clinical trials are carried out to try to find new and better treatments for cancer. Before any new cancer drug is licensed and available for general use it must be extensively tested to establish how safe and how effective it is. Scientists begin this process in the laboratory. These tests will have shown that the drug can kill cancer cells, and identified some of the possible side effects. Information taken from this extensive laboratory work can lead to the first testing of a drug in humans (a phase I trial). If the drug shows some promise it can then progress to phase ll and then phase lll trials.
Phase l trials
This is often the first time that the drug is given to humans, and the aim of this type of trial is to find a dose that can be given safely to patients. Only a small number are entered into this type of trial, sometimes as few as 20 patients. These trials are often not targeted at specific cancers, because the best tumour type to target with a new drug has not yet been established.
A phase l trial is designed to find out:
- how much drug can be given safely
- possible side effects of the drug
- how the drug is metabolised
- what effect the drug has on the body
- whether the drug has any effect on the cancer
If a safe dose has been found, the drug may then be tested in phase ll trials.
Cancer Early Phase Trials Unit at Guy’s Hospital
A range of phase I trials are open at this centre. The agents under investigation vary with time but include:
- small molecules
- monoclonal antibodies
- biological therapies
- Dr James Spicer, Clinical Reader in Experimental Oncology
- Dr Debashis Sarker, Clinical Senior Lecturer
- Kylie Gyertson, Clinical Trials Manager
- Gursharn Hutchins, Administration
Lead Phase 1 Research Nurse
Tel: 020 7188 7344
Tel: 020 7188 4260