MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 18, 2016

Primary Completion Date

June 26, 2018

Study Completion Date

November 24, 2020

Conditions
Hepatocellular CarcinomaLiver CancerHCC
Interventions
DRUG

MLN0128

Phase I Dose Escalation Study Cohort 1 MLN0128 15mg QW; Cohort 2 MLN0128 20mg QW; Cohort 3 MLN0128 30mg QW

DRUG

MLN0128 (RP2D)

"Phase II Arm A:~MLN0128 administered orally at the recommended phase II dose (RP2D) once weekly."

DRUG

Sorafenib

"Phase II Arm B:~Sorafenib administered at 400mg PO BID daily"

Trial Locations (6)

17033

Penn State Cancer Institute, Hershey

27514

University of Noth Carolina at Chapel Hill, Chapel Hill

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

53705

University of Wisconsin, Madison

60611

Northwestern University Feinberg School of Medicine, Chicago

60612

University of Illinois Cancer Center, Chicago

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

collaborator

Big Ten Cancer Research Consortium

OTHER

lead

Kathy Miller

OTHER