The purpose of the study AG636-C-001 is to determine the highest dose of AG-636 that can be safely given to subjects with lymphoma. We want to find out what effects, good or bad, AG-636 may have on you and your disease.
AG-636 is an oral chemotherapy medicine. It is not approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities around the world for the treatment of cancer or any other disease. Although AG-636 has been tested in laboratory models of cancer and in animals to understand its possible side effects, this is the first study in which AG-636 will be given to people.
AG-636 is an inhibitor of an enzyme called dihydroorotate dehydrogenase (DHODH). DHODH is involved in generating some of the building blocks needed for the production of DNA and RNA. By inhibiting DHODH and reducing the ability of the cancer cell to make DNA and RNA, the growth of cancer cells may be inhibited. In laboratory studies, it was found that certain cancers, such as lymphomas and leukemias, were particularly sensitive to the inhibition of DHODH.