Learn about Phase I Clinical Trials
What is a Phase I clinical trial?
Phase I clinical trials are the earliest phase of study treatment in people and may involve agents not yet available commercially or drugs already FDA-approved but given in a new way or in new combinations. Unique to these early-phase trials is the need to determine the appropriate dose of the treatment. This stage of the study is called “dose escalation.” Starting at doses far lower than those found to be safe in animals, the doses are slowly increased while safety is vigilantly monitored. Once the maximum tolerated dose has been determined, the study moves to the "expansion" phase where a larger number of patients are treated to further assess the safety of that dose. Although effectiveness of the treatment is certainly of interest in a Phase I study, later-phase studies are done to determine efficacy and compare the new treatment to standard treatments for the disease.
Phase I clinical trials are the earliest phase of a study treatment in people and may involve agents not yet available commercially or drugs already FDA-approved but given in a new way or in new combinations.
Historically, Phase I trials have only enrolled people who have exhausted all known standard treatments for their disease. With the development of better tolerated targeted biological therapy, people may be eligible for any phase of a study at any point in their treatment.
Who pays for the clinical trial?
The truly investigational portions of the treatment are paid for by the study fund and conducted at the UC Davis Comprehensive Cancer Center. However, certain tests, procedures or drugs given during the study period are considered routine care and will be billed to your insurance provider. Some insurance providers will require that these routine care items be handled by or through your referring oncologist.
What should I expect during my initial consultation with the doctor?
During a scheduled appointment in the Phase I clinic, the oncologist will explain the clinical trial that you might be eligible for and inform you of possible risks, benefits, the treatment and your rights in regard to clinical research participation. After a thorough explanation, you will be asked if you consent to participate in the study and, if so, to sign a consent form. You will likely meet the study coordinator responsible for the study at that time. From there, the study coordinator will arrange for screening procedures such as tests and scans to confirm your eligibility. Only then can you be enrolled on the clinical trial. At that point, an authorization coordinator will assist the study coordinator in developing a treatment plan calendar detailing where the tests or procedures will be performed.
If I am a patient from a non-UC Davis oncology group, can I keep my regular oncologist?
Yes, of course. However, all study-related treatment must be given at the UC Davis Comprehensive Cancer Center. In many cases, care has to be coordinated between UC Davis and your referring oncologist's office throughout the study period due to insurance requirements. All of your care will resume with your referring oncologist once the study treatment is completed.
Who do I contact for more information?
Please call our Phase I program manager with any questions at 916-703-5558.
You may also download our helpful cancer clinical trials patient information booklet.