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

Completed · Phase 1

Conditions studied: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

In brief

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).

Key facts

Study ID: NCT01498952
Run by: MedImmune LLC
People needed: 6
Starts: 2012-01-17
Expected to finish: 2013-04-09
Last updated by the study team: 2019-02-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;

You may not qualify if…

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

Where it is running

Research Site — Oxnard, California, United States
Research Site — Golden Springs, Colorado, United States
Research Site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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