|Status||OPEN TO ACCRUAL|
|Principal Investigator||O'Neil, Bert|
|Title||An Open Label Randomized Phase I/II Trial of MLN0128 Compared to Sorafenib in Patients with Advanced or Metastatic Hepatocellular Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI13-002|
|Description||This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses. Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or the sorafenib arm.|
|Key Eligibility||In order to be eligible to take part in this trial, patients must meet the following criteria:|
For a full list of participation criteria, please visit clinicaltrials.gov.
- Subjects must have a diagnosis of measurable advanced or metastatic hepatocellular carcinoma (HCC). Advanced HCC is defined as disease not amenable to surgery, ablation, transplant, or embolic therapy.
- Prior locoregional liver directed therapy is allowed as long as treatment was at least 6 weeks prior to study registration, and clear progression is demonstrated by RECIST v1.1 criteria. Subject must have recovered from the acute toxic effects (≤ grade 1 CTCAE v4) of previous anti-cancer treatment prior to study enrollment; the only exception is that grade 2 neuropathy is permitted.
|Applicable Disease Sites||Liver Cancer|
|Participating Institutions||Indiana University (IU)|
- Eskenazi Hospital
- Indiana University Hospital / IU Simon Cancer Center
- Spring Mill Medical Center