A Study of RO5137382 (GC33) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507168
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Placebo Drug: RO5137382 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
iv Days 1 and 8, and every 2 weeks thereafter
Experimental: RO5137382 (GC33) Drug: RO5137382
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Other Name: GC33

Primary Outcome Measures :
  1. Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: approximately 32 months ]
  2. Time to progression (TTP): Time from randomization to first documented disease progression [ Time Frame: approximately 24 months ]
  3. Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks [ Time Frame: approximately 24 months ]
  4. Safety: Incidence of adverse events [ Time Frame: approximately 24 months ]
  5. Pharmacokinetics: Serum concentrations (Cmax,Cmin) [ Time Frame: Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11 ]
  6. GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay [ Time Frame: at screening ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01507168

  Hide Study Locations
United States, California
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
United States, Maryland
Bethesda, Maryland, United States, 20889-0001
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10017
New York, New York, United States, 10032
United States, Tennessee
Nashville, Tennessee, United States, 37232-7610
United States, Texas
Houston, Texas, United States, 77005
United States, Washington
Seattle, Washington, United States, 98104
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
Angers, France, 49033
Clichy, France, 92118
Grenoble, France, 38 043
Marseille, France, 13385
Nice, France, 06202
Paris, France, 75571
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804
Berlin, Germany, 13353
Frankfurt Am Main, Germany, 60590
Freiburg, Germany, 79106
Heidelberg, Germany, 69120
Leipzig, Germany, 04103
Munich, Germany, 81675
Tübingen, Germany, 72076
Hong Kong
Pokfulam, Hong Kong
Shatin, Hong Kong
Benevento, Campania, Italy, 82100
Roma, Lazio, Italy, 00168
Milano, Lombardia, Italy, 20122
Padova, Veneto, Italy, 35128
Chiba, Japan, 277-8577
Ishikawa, Japan, 920-8641
Kanagawa, Japan, 241-8515
Osaka, Japan, 589-8511
Tokyo, Japan, 104-0045
Tokyo, Japan, 181-8611
Korea, Republic of
Busan, Korea, Republic of, 602-739
Gyeonggi-do, Korea, Republic of, 10408
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
New Zealand
Auckland, New Zealand, 100
Singapore, Singapore, 169610
Santander, Cantabria, Spain, 39008
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Madrid, Spain, 28007
Madrid, Spain, 28040
Madrid, Spain, 28041
Zaragoza, Spain, 50009
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 402
Taichung, Taiwan, 40705
Tainan, Taiwan, 00704
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
United Kingdom
Bebington, United Kingdom, CH63 4JY
London, United Kingdom, NW3 2QG
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01507168     History of Changes
Other Study ID Numbers: NP27884
2011-003574-84 ( EudraCT Number )
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases