a noncomparative study, meaning that the therapeutic effects and side effects of the agent are not compared to another drug or a placebo
a placebo controlled human trial conducted in a small number of patients (dozens to a few hundred), tracking side effects and dosage response, but now also therapeutic effect
a small clinical trial to determine the proper dose and administration of the drug
Phase II trials continue to test the safety of the new agent and begin to evaluate how well it works against a specific type of cancer. In these trials, the new agent is given to groups of people with one type of cancer or related cancers, using the dosage found to be safe in phase I trials. Usually the new agent is compared with a standard treatment in this type of trial.
Once the initial safety of the therapy has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess clinical efficacy of the therapy; as well as to continue Phase I assessments in a larger group of volunteers and patients.
an intermediate clinical trial for studying an experimental vaccine in humans. The goals of Phase II trials are usually to learn more about vaccine safety and to see if the vaccine generates an immune response. Phase II trials, which involve hundreds of participants, occur only after the experimental vaccine is shown to be safe in a smaller Phase I trial.
the second stage of the evaluation of a new drug in humans; these trials evaluate drug efficacy, involve more participants (often several hundred) and typically last longer than Phase I studies. Phase II trials may be divided into Phase IIa (pilot trials in patients with the disease to be treated) and phase IIb (well-controlled efficacy trials). Typically Phase II trials are done only if Phase I trials have shown the drug to be safe, but sometimes Phase I and Phase II studies are combined.
A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.
The second stage in testing a new drug in humans. Performed in patients with the disease or condition being studied. The main purpose is to evaluate the activity of a drug, and to possibly provide information on how well the drug works.
Controlled clinical study conducted to evaluate the effectiveness of a drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
Phase II trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. These studies are typically well controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
tests a substance in a limited number of patients to see if it is effective in a particular condition in the short term.
Trial to determine the effectiveness of a therapy or combination therapy. Patients in a Phase II Trial usually are those with refractory disease, and must have measurable disease so that the response to the investigational treatment can be evaluated. Phase II trials of the same therapy are often conducted on several different types of disease to determine if the therapy is effective for more than a single type of cancer.
Study of a group of similar patients to determine whether there is a statistical likelihood that a new treatment will be effective against a tumor.
a controlled clinical study conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II trials focus on learning whether the new treatment has an anticancer effect (for example, whether it shrinks a tumor, or improves blood test results), and whether it is effective for a particular type of cancer.