Status:
COMPLETED
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Lead Sponsor:
MedImmune LLC
Conditions:
Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01498952
Start Date
January 17 2012
End Date
April 9 2013
Last Update
February 19 2019
Active Locations (3)
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1
Research Site
Oxnard, California, United States, 93030
2
Research Site
Golden Springs, Colorado, United States, 80401
3
Research Site
Las Vegas, Nevada, United States, 89169