Advanced Hepatocellular CarcinomaPhase 2NCT00872014
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
A Phase 2 study testing AMG 386 and Sorafenib in people with Advanced Hepatocellular Carcinoma and Inoperable Hepatocellular Carcinoma, run by Amgen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Inoperable Hepatocellular Carcinoma
- What is being tested?
- AMG 386 and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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).
- Being tested
- AMG 386, Sorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 386Drug
Two doses of AMG 386 (15 mg/kg) IV QW will be studied
AMG 386Drug
Two doses of AMG 386 (10 mg/kg) IV QW will be studied
SorafenibDrug
Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort
| Study group | Role | What they receive |
|---|---|---|
| 15mg/ kg cohort | Experimental | AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. Receives: Drug: AMG 386; Drug: Sorafenib |
| 10 mg/kg cohort | Experimental | AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. Receives: Drug: AMG 386; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) rate at 4 months
Measured: 4 months
Secondary outcomes (6)
Incidence of adverse events and significant laboratory abnormalities
Measured: 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
Measured: Radiologic imaging every 8 weeks
Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib
Measured: Weeks 1, 2, 5, 9, and every 16 weeks thereafter
Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386
Measured: Weeks 2, 5, 9, and every 16 weeks thereafter
Incidence of the occurrence of anti-AMG 386 antibody formation
Measured: 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
Measured: Weeks 1, 2, 5, and every 16 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872014
- Sponsor's protocol ID
- 20080580
- Status last verified
- Feb 2016
- First submitted
- 12 Mar 2009
- Last updated
- 4 Apr 2016
- Results posted
- No
Publications
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.
PubMed 28592620
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00872014
- Acronym / sponsor ID
- 20080580
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15mg/ kg cohort | Experimental | Drug: AMG 386, Drug: SorafenibAMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. |
| 10 mg/kg cohort | Experimental | Drug: AMG 386, Drug: SorafenibAMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 386Two doses of AMG 386 (15 mg/kg) IV QW will be studied | Drug | 15mg/ kg cohort |
| AMG 386Two doses of AMG 386 (10 mg/kg) IV QW will be studied | Drug | 10 mg/kg cohort |
| SorafenibSorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort | Drug | 10 mg/kg cohort, 15mg/ kg cohort |
Primary outcome
Progression free survival (PFS) rate at 4 months
Time frame: 4 months
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Derived from this study: PubMed 28592620Abou-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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 386 and Sorafenib in people with Advanced Hepatocellular Carcinoma and Inoperable Hepatocellular Carcinoma, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) rate at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.