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A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872014
First Posted: March 30, 2009
Last Update Posted: April 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy.

Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.


Condition Intervention Phase
Advanced Hepatocellular Carcinoma Inoperable Hepatocellular Carcinoma Drug: AMG 386 Drug: Sorafenib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression free survival (PFS) rate at 4 months [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks ]
  • Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression [ Time Frame: Radiologic imaging every 8 weeks ]
  • Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib [ Time Frame: Weeks 1, 2, 5, 9, and every 16 weeks thereafter ]
  • Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386 [ Time Frame: Weeks 2, 5, 9, and every 16 weeks thereafter ]
  • Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: Weeks 1, 5, 9, and every 16 weeks thereafter ]
  • Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers [ Time Frame: Weeks 1, 2, 5, and every 16 weeks thereafter ]

Enrollment: 60
Study Start Date: August 2009
Study Completion Date: June 2015
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15mg/ kg cohort
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Drug: AMG 386
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Drug: Sorafenib
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort
Experimental: 10 mg/kg cohort
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Drug: AMG 386
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
Drug: Sorafenib
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort

Detailed Description:
The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed advanced or inoperable HCC
  • Child-Pugh A liver function score
  • Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications
  • Adequate organ and hematological function
  • Men or women greater than or equal to 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria:

  • Subject is eligible for a liver transplant per investigators discretion
  • Any previous systemic chemotherapy for HCC
  • History of arterial or venous thromboembolism within 12 months prior to enrollment
  • History of clinically significant bleeding within 6 months prior to enrollment
  • History of central nervous system metastases
  • Clinically significant cardiovascular disease within 12 months
  • Uncontrolled hypertension
  • Subjects with a history of prior malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872014


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00872014     History of Changes
Other Study ID Numbers: 20080580
First Submitted: March 12, 2009
First Posted: March 30, 2009
Last Update Posted: April 4, 2016
Last Verified: February 2016

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
Trebananib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors


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