MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.



Status:Completed
Conditions:Liver Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/21/2019
Start Date:January 17, 2012
End Date:April 9, 2013

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A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma

A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard
of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).


Inclusion Criteria:

- Age ≥ 18 years or minimum age of consent per local regulations at the time of
screening

- Unresectable or metastatic hepatocellular carcinoma

- ECOG Performance Status ≤ 2

- Life expectancy of ≥ 3 months;

Exclusion Criteria:

- Child-Pugh Score for Cirrhosis Mortality > 7 points

- Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic,
targeted or experimental therapy

- Prior local treatment for HCC less than 4 weeks prior to initiating study treatment

- Active second malignancy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to
initiating study treatment

- Thrombotic or embolic events within 6 months prior to initiating study treatment

- Ongoing pancreatitis

- Uncontrolled or refractory ascites

- Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known
leptomeningeal carcinomatosis

- Hepatic encephalopathy > Grade 1

- Active brain metastases with exceptions

- Poorly controlled diabetes mellitus

- Active coronary artery disease

- Uncontrolled hypertension
We found this trial at
3
sites
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Golden Springs, CO
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Las Vegas, NV
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Oxnard, CA
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