A Phase II Study of Avatrombopag to Treat Thrombocytopenia in People with Cancer

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Full Title

Clinical Trial of Avatrombopag for Thrombocytopenia in Cancer, A Phase II Single Arm Study

Purpose

The purpose of this study is to see if the drug avatrombopag can boost platelet production in people who cannot begin chemotherapy because their platelet count is too low (thrombocytopenia) due to cancer and a liver disease such as cirrhosis, cholangitis, or hepatitis. Platelets are cells in the blood that help blood clot.

Chemotherapy can cause or worsen thrombocytopenia. In this study, researchers want to see if avatrombopag can enable people with thrombocytopenia to start chemotherapy. They also want to know if avatrombopag can continue to be effective against thrombocytopenia while patients receive chemotherapy for 12 weeks or longer.

The U.S. Food and Drug Administration has approved avatrombopag to treat thrombocytopenia in people with chronic liver disease who are about to have a medical or dental procedure. Its use in this study is considered investigational. Avatrombopag 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 advanced cancer and liver disease that is causing thrombocytopenia.
  • Patients may not have previously received chemotherapy for the current cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gerald Soff at 646-608-2023.

Protocol

19-483

Phase

II

Investigator