Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

Thank you

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 SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteLas Vegas, Nevada