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

• Status: Completed
• Trial end date: 2013-04-09
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Niacinamide; Sorafenib

Criteria

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