Clinical trials (also known as clinical research or clinical studies) are conducted to determine if an investigational agent is effective and safe.
There are four phases of clinical trials in cancer treatment:
- Phase I: An investigational drug is tested in a small group of people to determine a safe dose range and identify side effects.
- Phase II: The investigational drug is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The investigational drug is given to large groups of people to compare its effectiveness to commonly used therapies and monitor side effects.
- Phase IV: After the investigational drug has been approved for marketing, Phase IV clinical trials investigate the agent’s effectiveness in various patient populations and determine side effects associated with long-term treatment.
Since 1993, patients with a variety of advanced cancers have been enrolled in Phase II clinical trials of Antineoplastons. Currently, new FDA-reviewed phase II and III clinical trials utilizing Antineoplastons are undergoing Institutional Review Board (IRB) approval.