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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced or Inoperable Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS) rate at 4 months

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Human Research Ethics Committee

Study ID:

20080580

NCT ID:

NCT00872014

Start Date:

August 2009

Completion Date:

June 2015

Related Keywords:

  • Advanced or Inoperable Hepatocellular Carcinoma
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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