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Trial Summary

Protocol No.BTCRC-GI13-002
StatusOPEN TO ACCRUAL
Principal InvestigatorO'Neil, Bert
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleAn 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
DescriptionThis 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 EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • 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.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLiver Cancer
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment