MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.

NCT ID: NCT01498952

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-17
• Study Completion Date: 2013-04-09

Brief Summary

A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b Cohort A

Participants will receive MEDI-573 10 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Group Type: EXPERIMENTAL

MEDI-573 (1 of 3 doses)

Intervention Type: DRUG

MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands

Sorafenib

Intervention Type: DRUG

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Phase 1b Cohort B

Participants will receive MEDI-573 45 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Group Type: EXPERIMENTAL

MEDI-573 (1 of 3 doses)

Intervention Type: DRUG

MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands

Sorafenib

Intervention Type: DRUG

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Phase 1b Cohort C

Participants will receive MEDI-573 30 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Group Type: EXPERIMENTAL

MEDI-573 (1 of 3 doses)

Intervention Type: DRUG

MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands

Sorafenib

Intervention Type: DRUG

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Phase 2 Arm 1

Participants will receive recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Group Type: EXPERIMENTAL

MEDI-573 (1 of 3 doses)

Intervention Type: DRUG

MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands

Sorafenib

Intervention Type: DRUG

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Phase 2 Arm 2

Participants will receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Interventions

MEDI-573 (1 of 3 doses)

MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands

Intervention Type: DRUG

Sorafenib

Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years or minimum age of consent per local regulations at the time of screening
• Unresectable or metastatic hepatocellular carcinoma
• ECOG Performance Status ≤ 2
• Life expectancy of ≥ 3 months;

Exclusion Criteria

• Child-Pugh Score for Cirrhosis Mortality > 7 points
• Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic, targeted or experimental therapy
• Prior local treatment for HCC less than 4 weeks prior to initiating study treatment
• Active second malignancy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment
• Thrombotic or embolic events within 6 months prior to initiating study treatment
• Ongoing pancreatitis
• Uncontrolled or refractory ascites
• Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis
• Hepatic encephalopathy > Grade 1
• Active brain metastases with exceptions
• Poorly controlled diabetes mellitus
• Active coronary artery disease
• Uncontrolled hypertension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Perez, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Research Site

Oxnard, California, United States

Research Site

Golden Springs, Colorado, United States

Research Site

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

CD-ON-MEDI-573-1028

Identifier Type: -

Identifier Source: org_study_id