A Phase IB Study of Dalantercept plus Sorafenib in Patients with Advanced Liver Cancer

Protocol
14-092
Full Title
A Phase 1b, Open Label Study of Dalantercept plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma
Phase
II
Purpose

Sorafenib is a drug approved for the treatment of hepatocellular carcinoma (liver cancer). It works by targeting several proteins involved in cancer growth. However, despite this treatment, the cancer often comes back or spreads. Doctors are therefore seeking more effective therapies for liver cancer.

In this study, researchers want to find the highest dose of the investigational drug dalantercept that can be given with sorafenib in patients with hepatocellular carcinoma that has continued to grow despite prior therapy or has spread. Dalantercept is designed to inhibit tumor growth by blocking the development of the blood vessels that tumors need to grow and spread.

Sorafenib is taken orally (by mouth), while dalantercept is given as an injection under the skin.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have hepatocellular carcinoma that has continued to grow despite prior therapy or has spread.
  • Patients may not have previously received sorafenib, dalantercept, or any other therapies that target RAF/VEGF or ALK1.
  • Patients may not have had prior chemotherapy for metastatic liver cancer.
  • Patients must have recovered from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Disease(s)
Hepatobiliary: Liver Cancer
Locations
Related Diseases