|PEG-SN38 (EZN-2208)||2||Metastatic breast cancer|
|2||Metastatic colorectal cancer|
|HIF-1α antagonist||1||Solid tumors, lymphoma|
|1||Solid tumors, primarily in liver|
|Survivin antagonist||1||Solid tumors, lymphoma|
|1||Pediatric acute lymphoblastic leukemia|
|AR antagonist||1||Prostate cancer|
Promising new agents first undergo pre-clinical testing in test tube and in animals and are designated by the U.S. Food and Drug Administration (FDA) as an Investigational New Drug if the pre-clinical data is positive. Research then moves on to clinical testing in people through Phase I, II and III clinical trials.
In Phase I trials, researchers test an experimental drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, the FDA has already granted approval, but the study may identify an additional use or gather more safety information. These studies can also provide information on how the drug may be best used or best combined with other treatments.
For more information about clinical trials, please visit ClinicalTrials.gov.