A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

The purpose of this study is to help in answering the following research questions:

1. How safe is ribociclib in combination with belinostat? What, if any, side effects will occur during the combination treatment?
2. What effect the study treatment combination may have on the disease.

The combination of ribociclib and belinostat has not been approved by the U.S Food and Drug Administration (FDA) so this combination is being considered “investigational” for use in this study. An investigational drug is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

Ribociclib is an anti-cancer agent which is approved in the United States (US) to treat patients with estrogen receptor-positive breast cancer. However, it has not been FDA approved to treat patients with triple negative breast cancer or ovarian cancer.

Belinostat is approved by the FDA for the treatment of lymphomas. However, it has not been FDA approved to treat patients with triple negative breast cancer or ovarian cancer.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

• 18 years of age or older
• Able to swallow pills
• Pathologically confirmed breast cancer with the following features:
  • Measurable disease by RECIST 1.1;
  • ER and PR ≤ 1% by immunohistochemistry;
  • Her-2/neu negative (0 or 1+ by immunohistochemistry OR not-amplified by CAP/ASCO standards);
  • Metastatic or unresectable and locally advanced and not amenable to treatment with curative intent, in the opinion of the enrolling investigator.
  • OR
  • Platinum-resistant (defined as progression within 12 months of last platinum therapy administration), pathologically confirmed serous ovarian cancer that is recurrent and unresectable, in the opinion of the enrolling investigator
  • Metastatic or unresectable and locally advanced and not amenable to treatment with curative intent, in the opinion of the enrolling investigator
• Additional eligibility in protocol

• Previous use of CDK 4/6 or HDAC inhibitors for cancer treatment
• Pregnancy/nursing
• Prior treatment with an anti PD-1, anti PD-L1, anti-PD-L2, or anti CTLA-4 antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Known active CNS metastases and/or brain metastases, leptomeningeal disease
• Uncontrolled arrhythmia, congestive heart failure or angina
• Some herbal supplements may need to be stopped prior to treatment
• Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment
• Known chronic hepatitis B virus (HBV) or hepatitis C virus infection with a detectable viral load
• Additional ineligibility in protocol

For additional information, please see: https://www.clinicaltrials.gov/ct2/show/ NCT04315233