What are Early Phase Clinical Trials?

The Phase I Trial

Phase I is the initial phase of the clinical trial which is carried out to find out how safe and how effective a drug (or drug combination) is at treating cancer.  These are usually dose-escalation studies whereby a series of groups (or cohorts) of patients are given the trial drug at different dose levels. Patients participating in the trial will continue to receive the study drug at regular intervals for a set period of time (e.g. 6 cycles) or indefinitely unless there is evidence that their cancer is growing or they experience significant side effects. Depending on the study, the drug is given by mouth (orally), by injection into a vein (IV), injection into the skin (subcutaneously), injection into the tumour (intratumoural) or in a combination of these ways. An important part of the study is for us to understand how effective the drug is. CT scans (or other scans such as ultrasound, MRI or PET scans) are conducted at the start of the study and repeated at regular intervals to assess whether the cancer is shrinking or becoming stable (not growing or shrinking by a significant amount).  We also need to understand what side effects the drug/s might be causing. Our research team will review and record your symptoms at each of your visits and conduct regular blood tests of your body’s organs (such as your liver, thyroid, kidneys and bone marrow) to check whether they are affected. Depending on what we already know about the drug, we may conduct tests on other organs in your body at the start of the treatment (and/or later in the study), such as your heart, lungs or eyes for example.  If any of these tests become significantly abnormal during the study, we will either reduce the dose of the study drug or discontinue it. To understand how the drug is behaving in your body, we will do additional blood tests such as urine samples or we may need to take a piece of your skin (a skin biopsy) or of your tumour (tumour biopsy) during your study participation.  The phase I trial is concluded when we identify the safest and/or most effective dose of the study drug to use.

How do I get a referral to enter a phase I trial?

We cannot take direct referrals from patients but accept referrals from their oncologists or GPs. Referrals should be sent by post or email - orh-tr.oncology1@nhs.net for details.