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

Purpose

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 HCC.

Condition	Intervention	Phase
Unresectable or Metastatic Hepatocellular Carcinoma (HCC)	Drug: MEDI-573 (1 of 3 doses) Drug: Sorafenib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Phase Ib: (Dose Evaluation Phase): Safety and Tolerability of 2 Dose Levels of MEDI-573 Combined with Standard of Care (SOC) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
The primary objective of the dose-evaluation phase of this study (Phase 1b) is to evaluate the safety and tolerability of MEDI-573 in combination with SOC in subjects with unresectable or metastatic HCC. This will be measured by the number of adverse events, serious adverse events, and laboratory changes from baseline.

Secondary Outcome Measures:

Pharmacokinetics (PK) of MEDI-573 [ Time Frame: 19 Months ] [ Designated as safety issue: No ]
To describe the pharmacokinetics (PK) of MEDI-573 in combination with SOC in the Phase 1b and Phase 2 portions of this study.
Immunogenicity of MEDI-573 [ Time Frame: 19 Months ] [ Designated as safety issue: Yes ]
To determine the immunogenicity (IM) of MEDI-573 in combination with SOC in the Phase 1b and Phase 2 portions of this study.

Estimated Enrollment:	6
Study Start Date:	January 2012
Estimated Study Completion Date:	May 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort A MEDI-573 Dose 1 plus Sorafenib	Drug: 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 Drug: Sorafenib Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
Experimental: Cohort B MEDI-573 Dose 2 plus Sorafenib	Drug: 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 Drug: Sorafenib Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
Experimental: Cohort C MEDI-573 Dose 2 plus sorafenib	Drug: 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 Drug: Sorafenib Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498952

Locations

United States, California
Research Site
Oxnard, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
Research Site
Golden Springs, Colorado, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Susan Perez, MD

MedImmune LLC

More Information

No publications provided

Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT01498952 History of Changes
Other Study ID Numbers:	CD-ON-MEDI-573-1028
Study First Received:	November 29, 2011
Last Updated:	May 14, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by MedImmune LLC:

HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC. (MEDI-573-1028)