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A Randomized, Multi-Center, Blinded, Placebo-Controlled Study Of Mapatumumab ([HGS1012], A Fully Monoclonal Antibody To TRAIL-R1) In Combination With Sorafenib As A First-Line Therapy In Subjects With Advanced Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Randomized, Multi-Center, Blinded, Placebo-Controlled Study Of Mapatumumab ([HGS1012], A Fully Monoclonal Antibody To TRAIL-R1) In Combination With Sorafenib As A First-Line Therapy In Subjects With Advanced Hepatocellular Carcinoma


Inclusion Criteria:



- Child-Pugh Class A

- BCLC Stage B or C

- Measurable Liver Cancer

- ECOG Performance Status of 0, 1, or 2

- Age 18 years or older

Exclusion Criteria:

- Received prior investigational or non-investigational agent to treat hepatocellular
carcinoma

- Previously received mapatumumab and/or sorafenib

- Major surgery within 4 weeks before enrollment

- Minor surgery within 2 weeks before enrollment

- Systemic steroids within 1 week of enrollment

- Hepatic encephalopathy

- History of clinically significant gastrointestinal bleeding

- Gastrointestinal disease resulting in the inability to take oral medication

- History of infection requiring hospitalization or IV antibiotics

- Known brain or spinal cord metastases

- Known HIV infection

- Unstable angina, myocardial infarction, or cerebrovascular accident within 6 months
before enrollment

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or
digoxin

- Uncontrolled hypertension

- Using and unable to discontinue use of CYP3A4 inducers

- Pregnant or breast-feeding women

- Acute or chronic severe renal insufficiency

- Hepatitis B virus DNA levels >2,000IU/mL

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HGS1012-C1103

NCT ID:

NCT01258608

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

UMDNJ University HospitalNewark, New Jersey  07103
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033
North Mississippi Hematolgy and Oncology Associates, ltdTupelo, Mississippi  38801
UPMC Cancer Center- Hillman Cancer CenterPittsburgh, Pennsylvania  15232