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Completed

NCT Number: NCT00872014

A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

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.

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Key information

Conditions

Advanced Hepatocellular Carcinoma Inoperable Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 386

Drug

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

Sorafenib

Drug

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

Primary outcomes

  1. Progression free survival (PFS) rate at 4 months

    Time frame: 4 months

Secondary outcomes

  1. Incidence of adverse events and significant laboratory abnormalities

    Time frame: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks

  2. Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression

    Time frame: Radiologic imaging every 8 weeks

  3. Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib

    Time frame: Weeks 1, 2, 5, 9, and every 16 weeks thereafter

  4. Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386

    Time frame: Weeks 2, 5, 9, and every 16 weeks thereafter

  5. Incidence of the occurrence of anti-AMG 386 antibody formation

    Time frame: Weeks 1, 5, 9, and every 16 weeks thereafter

  6. 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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Mar 30, 2009
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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