Full TitlePhase 1/2 Open Label, Multi-center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Fimepinostat (CUDC 907), a PI3K and HDAC Inhibitor, in Subjects with Relapsed and/or Refractory Lymphoma
The treatment of relapsed lymphoma remains challenging. Despite conventional treatment approaches, such as chemotherapy and radiation therapy, the disease persists in many patients. The goal of this study is to find the highest dose of an investigational drug called CUDC-907 that can be given safely in patients with relapsed lymphoma that has persisted or returned despite standard therapy, and to evaluate its potential effects against lymphoma.
CUDC-907 is designed to reduce cancer growth by inhibiting two enzymes inside the lymphoma cells: histone deacetylase (HDAC) and PI3 kinase (PI3K). Drugs that target just one of these pathways at a time have shown to be effective for reducing lymphoma cell growth, but CUDC-907 is different in that it targets both pathways, making it potentially more effective. CUDC-907 is a tablet that is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have lymphoma or multiple myeloma that has returned or continued to grow after at least two prior regimens of therapy.
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 and older.