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MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma

NCT02575339 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-07-26

Study results available
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Summary

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.

Conditions

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

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Kathy Miller

    lead OTHER

Principal Investigators

  • Kathy D Miller, M.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-18
Primary Completion
2018-06-26
Completion
2020-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575339 on ClinicalTrials.gov