Clinical trial NCT00872014: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Inoperable Hepatocellular Carcinoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Progression free survival (PFS) rate at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Incidence of adverse events and significant laboratory abnormalities
timeFrame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks
measure: Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression
timeFrame: Radiologic imaging every 8 weeks
measure: Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib
timeFrame: Weeks 1, 2, 5, 9, and every 16 weeks thereafter
measure: Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386
timeFrame: Weeks 2, 5, 9, and every 16 weeks thereafter
measure: Incidence of the occurrence of anti-AMG 386 antibody formation
timeFrame: Weeks 1, 5, 9, and every 16 weeks thereafter
measure: Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers
timeFrame: Weeks 1, 2, 5, and every 16 weeks thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.