MEDI-573 in Combination with SOC in Unresectable or Metastatic HCC. - MEDI-573-1028
Study identifier:CD-ON-MEDI-573-1028
ClinicalTrials.gov identifier:NCT01498952
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Unresectable or metastatic hepatocellular carcinoma (HCC)
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI-573 (1 of 3 doses), Sorafenib
Sex
All
Actual Enrollment
6
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 17 Jan 2012
Primary Completion Date: 09 Apr 2013
Study Completion Date: 09 Apr 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 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. | 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: 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. | 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: 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. | 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: 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. | 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 |
| Active Comparator: 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. | Drug: Sorafenib Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor |
Contacts
Investigators
Principal Investigator
Susan Perez
MedImmune, LLC
