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Phase II Study of AMG 386 and Sorafenib as First-Line Therapy for Patients with Advanced or Inoperable Hepatocellular Carcinoma
[Protocol 09-076]
- Full Title :
- A PHASE II 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
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of combining sorafenib with AMG 386 in patients with advanced or inoperable liver cancer. AMG 386 is an investigational drug called an anti-angiogenic peptibody. Anti-angiogenic peptibodies stop a specific target called angiopoietin, which helps liver cancer grow.
Sorafenib is already approved for the treatment of liver cancer. It works by stopping a signal made by cancer cells, which they need to multiply and grow, and through inhibiting blood supply to cancer cells. Sorafenib is a capsule that is taken by mouth.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of advanced, inoperable, or metastatic hepatocellular carcinoma.
- Patients may have received local therapy but not systemic therapy for liver cancer. Prior treatment with sorafenib is not permitted.
- At least 4 weeks must have passed since any major surgery and 2 weeks since radiation therapy and entry into the study.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 212-639-3112.
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