Phase I Trials--Determining safety.
The goal of a Phase I trial is to find the safest dose of a new drug that patients can receive without creating side effects that would be too harmful for the patients. During a Phase I trial, the researcher also examines the best way to give a new drug, such as by mouth or intravenously (through a vein). Throughout Phase I trials, researchers monitor whether the new drug shows any effect against cancer. However, because these trials often are testing drugs for the first time in people, the goal is to find out how to give the drug in a safe way, and not how well it fights cancer. Many people who enter Phase I trials have a relatively poor prognosis after undergoing other treatments and are strongly motivated to help in the fight against their cancer. Phase I trials usually include 15 to 30 people.
Typically, patients in Phase I trials are divided into cohorts--small groups of patients--usually around three people. The first cohort receives a low dose of the new drug. Researchers may collect blood or urine samples to measure drug levels in the patients. If no severe side effects happen, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the researchers see too many side effects or until they determine the best dose. If the treatment successfully passes through a Phase I trial, then it will move forward to be studied in a Phase II trial.
Usually patients who have already taken standard treatments without success and do not have other effective cancer treatment options are eligible to participate in a Phase I trial.
