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Clinical Trials/EUCTR2008-006212-38-DE
EUCTR2008-006212-38-DE
Active, not recruiting
Not Applicable

Phase 2, Open-label Single-Arm, 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. - Not applicable

Amgen Inc0 sites60 target enrollmentApril 14, 2009
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Conditionsadvanced or inoperable hepatocellular carcinomaMedDRA version: 17.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
advanced or inoperable hepatocellular carcinoma
Sponsor
Amgen Inc
Enrollment
60
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 14, 2009
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amgen Inc

Eligibility Criteria

Inclusion Criteria

  • •Disease Related
  • •Subjects must have histologically confirmed advanced or inoperable HCC. Biopsy by fine needle aspirate (FNA) is not preferred over a core biopsy but acceptable
  • •Child\-Pugh liver function class A (see Appendix G)
  • •Measurable disease with at least one unidimensionally measurable lesion per RECIST criteria 1\.0 with modifications (see Appendix E).
  • •Demographic
  • •Men or women \= 18 years old
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • •Subjects of child\-bearing potential and sexually active must consent to the use of an accepted and effective non\-hormonal method of contraception (ie, double barrier method \[eg, condom plus diaphragm]) from signing the informed consent through 6 months following last administration of study drug
  • •Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrollment:
  • •o Hematological function, as follows:

Exclusion Criteria

  • •Disease Related
  • •Subject is eligible for liver transplant per investigator’s discretion
  • •Any previous systemic chemotherapy for HCC (chemotherapy or targeted therapies)
  • •Previous surgical resections are allowed if \= 30 days elapsed prior to enrollment
  • •Locoregional therapies (eg, TACE) are allowed if \= 30 days elapsed prior to enrollment provided that subjects either have a target lesion which has not been subjected to local therapy and/or the target lesions(s) within the field of the local therapy has shown an increase of \= 20% in size
  • •History of arterial or venous thromboembolism within 12 months prior to enrollment
  • •o Subjects with portal vein thrombosis are eligible for this study
  • •except those with main portal vein thrombosis defined as the part of
  • •the portal vein between the inferior vena cava and the first
  • •bifurcation into the left and right vein

Outcomes

Primary Outcomes

Not specified

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