NCT00872014

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

March 12, 2009

Last Update Submit

March 7, 2016

Conditions

Advanced Hepatocellular CarcinomaInoperable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) rate at 4 months

    4 months

Secondary Outcomes (6)

  • Incidence of adverse events and significant laboratory abnormalities

    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

    Radiologic imaging every 8 weeks

  • Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib

    Weeks 1, 2, 5, 9, and every 16 weeks thereafter

  • Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386

    Weeks 2, 5, 9, and every 16 weeks thereafter

  • Incidence of the occurrence of anti-AMG 386 antibody formation

    Weeks 1, 5, 9, and every 16 weeks thereafter

  • +1 more secondary outcomes

Study Arms (2)

15mg/ kg cohort

EXPERIMENTAL

AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.

Drug: AMG 386Drug: 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.

Drug: AMG 386Drug: Sorafenib

Interventions

AMG 386DRUG

Two doses of AMG 386 (15 mg/kg) IV QW will be studied

15mg/ kg cohort
SorafenibDRUG

Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort

10 mg/kg cohort15mg/ kg cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28592620DERIVED

Related Links

MeSH Terms

Interventions

trebananibSorafenib

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 30, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2011

Study Completion

June 1, 2015

Last Updated

April 4, 2016

Record last verified: 2016-02