Back to resultsA Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
Primary Purpose
Advanced Hepatocellular Carcinoma, Inoperable Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 386
AMG 386
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
15mg/ kg cohort
10 mg/kg cohort
Arm Description
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Outcomes
Primary Outcome Measures
Progression free survival (PFS) rate at 4 months
Secondary Outcome Measures
Incidence of adverse events and significant laboratory abnormalities
Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression
Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib
Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386
Incidence of the occurrence of anti-AMG 386 antibody formation
Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872014
Brief Title
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma, Inoperable Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15mg/ kg cohort
Arm Type
Experimental
Arm Description
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Arm Title
10 mg/kg cohort
Arm Type
Experimental
Arm Description
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
Intervention Type
Drug
Intervention Name(s)
AMG 386
Intervention Description
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Intervention Type
Drug
Intervention Name(s)
AMG 386
Intervention Description
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort
Primary Outcome Measure Information:
Title
Progression free survival (PFS) rate at 4 months
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events and significant laboratory abnormalities
Time Frame
Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks
Title
Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression
Time Frame
Radiologic imaging every 8 weeks
Title
Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib
Time Frame
Weeks 1, 2, 5, 9, and every 16 weeks thereafter
Title
Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386
Time Frame
Weeks 2, 5, 9, and every 16 weeks thereafter
Title
Incidence of the occurrence of anti-AMG 386 antibody formation
Time Frame
Weeks 1, 5, 9, and every 16 weeks thereafter
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28592620
Citation
Abou-Alfa GK, Blanc JF, Miles S, Ganten T, Trojan J, Cebon J, Liem AK, Lipton L, Gupta C, Wu B, Bass M, Hollywood E, Ma J, Bradley M, Litten J, Saltz LB. Phase II Study of First-Line Trebananib Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma. Oncologist. 2017 Jul;22(7):780-e65. doi: 10.1634/theoncologist.2017-0058. Epub 2017 Jun 7.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
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