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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01498952
First received: November 29, 2011
Last updated: November 26, 2013
Last verified: November 2013
  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:


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.


Enrollment: 6
Study Start Date: January 2012
Study Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: November 26, 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, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 September 30, 2014