- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872014
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 15mg/ kg cohort
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
|
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
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.
|
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort & 10mg/kg cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival (PFS) rate at 4 months
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events and significant laboratory abnormalities
Time Frame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks
|
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
|
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
|
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
|
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
|
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
|
Weeks 1, 2, 5, and every 16 weeks thereafter
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sorafenib
- Trebananib
Other Study ID Numbers
- 20080580
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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