July 22, 2016:
The Big Ten Cancer Research Consortium (Big Ten CRC) announces the opening of a Phase I/II clinical trial for advanced or metastatic hepatocellular carcinoma.
The study, known as BTCRC-GI13-002, will be conducted in two phases. In Phase I, researchers will determine the maximum safe dose of a drug called MLN0128. In Phase II, study participants will be randomized to one of two groups. One group will receive MLN0128 and the other will receive sorafenib, the standard therapy for patients with advanced or metastatic hepatocellular carcinoma.
MLN0128 is an investigational drug. This means it has not been approved by the U.S. Food and Drug Administration to treat any disease.
The Indiana University Melvin and Bren Simon Cancer Center in Indianapolis is currently enrolling participants in this study. Additional member sites within the Big Ten Cancer Research Consortium will open the trial in the coming months.
Bert H. O’Neil, MD, Joseph W. and Jackie J. Cusick Professor of Oncology at the Indiana University School of Medicine and a researcher at the IU Simon Cancer Center, is the sponsor investigator of the study. Read More
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