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A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

Thank you

Trial Information

A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)

- Prior treatment with at least 1 systemic agent, with documented progressive disease
after systemic agent(s), or documented adverse event(s) associated with prior
systemic agent(s) that resulted in discontinuance of that (those) agent(s)

- Not a candidate for curative treatments (e.g. resection, transplantation)

- Child-Pugh A (score of 5-6)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic, hepatic and renal function

- Ability to provide, for central review, a tumor tissue sample to determine the level
of GPC-3 expression by IHC

- Measurable disease by RECIST criteria

Exclusion Criteria:

- Child Pugh B or C

- Known hepatocellular carcinoma with fibro-lamellar histology

- Known brain or leptomeningeal metastases

- Active infectious diseases requiring treatment except for hepatitis B and C

- History of organ allograft including liver transplant

- Anticipated or ongoing administration of anticancer therapies other than those
administered in this study

- Anticancer treatment within 2 weeks prior to entering the study

- Patients who have not fully recovered from toxicities associated with previous HCC
loco-regional or systemic therapies

- Patients receiving interferon therapy

- Pregnant or lactating women

- Known HIV positivity or AIDS-related illness

- History of significant hypersensitivity to similar agents (monoclonal antibody,
protein-included drugs, Chinese hamster ovary products)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (tumor assessments according to RECIST criteria)

Outcome Time Frame:

approximately 24 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NP27884

NCT ID:

NCT01507168

Start Date:

February 2012

Completion Date:

February 2015

Related Keywords:

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

Name

Location

Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Baltimore, Maryland  21287