A Phase I Study of CUDC-907 in Patients with Relapsed or Refractory Lymphoma or Multiple Myeloma

Protocol
13-045
Full Title
Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects with Refractory or Relapsed Lymphoma or Multiple Myeloma
Phase
I
Disease Status
Relapsed/Refractory
Purpose

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).

Eligibility

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.

For more information and to inquire about eligibility for this study, please contact Dr. Anas Younes at 212-639-7715 or Amy Copeland, Research Clinical Nurse Specialist, at 212-639-6104.

Disease(s)
Hematology: Multiple Myeloma
Lymphoma: Non-Hodgkin's Lymphoma
Locations

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »