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 |
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).
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
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