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
18 Years
N/A
Both
Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase Ib: (Dose Evaluation Phase): Safety and Tolerability of 2 Dose Levels of MEDI-573 Combined with Standard of Care (SOC)
Outcome Description:
The primary objective of the dose-evaluation phase of this study (Phase 1b) is to evaluate the safety and tolerability of MEDI-573 in combination with SOC in subjects with unresectable or metastatic HCC. This will be measured by the number of adverse events, serious adverse events, and laboratory changes from baseline.
Outcome Time Frame:
6 Months
Safety Issue:
Yes
Principal Investigator
Susan Perez, MD
Investigator Role:
Study Director
Investigator Affiliation:
MedImmune LLC
Authority:
United States: Food and Drug Administration
Study ID:
CD-ON-MEDI-573-1028
NCT ID:
NCT01498952
Start Date:
January 2012
Completion Date:
May 2013
Related Keywords:
- Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
- HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Las Vegas, Nevada |
