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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01507168
First received: January 6, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This randomized, placebo-controlled, multicenter study will evaluate the efficac y and safety of RO5137382 (GC33) in previously treated patients with unresectabl e advanced or metastatic hepatocellular carcinoma. Patients will be stratified a ccording to the level of GPC-3 expression in tumors and randomized to receive ei ther 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 Intervention Phase
Liver Cancer
Drug: RO5137382
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: approximately 32 months ] [ Designated as safety issue: No ]
  • Time to progression (TTP): Time from randomization to first documented disease progression [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay [ Time Frame: at screening ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5137382 (GC33) Drug: RO5137382
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Placebo Comparator: Placebo Drug: Placebo
iv Days 1 and 8, and every 2 weeks thereafter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507168

  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90095
Los Angeles, California, United States, 90033
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, 10065
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
Belgium
Bruxelles, Belgium, 1070
Gent, Belgium, 9000
France
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
Germany
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
Hong Kong, Hong Kong
Pokfulam, Hong Kong
Italy
Benevento, Campania, Italy, 82100
Roma, Lazio, Italy, 00168
Milano, Lombardia, Italy, 20122
Padova, Veneto, Italy, 35128
Japan
Kanagawa, Japan, 241-8515
Kanazawa, Japan, 920-8641
Kashiwa, Japan, 277-8577
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, 410-769
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 120-749
New Zealand
Auckland, New Zealand, 100
Singapore
Singapore, Singapore, 169610
Spain
Santander, Cantabria, Spain, 39008
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28007
Zaragoza, Spain, 50009
Taiwan
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 40705
Taichung, Taiwan, 402
Tainan, Taiwan, 00704
Taipei, Taiwan, 100
Taipei, Taiwan, 00112
Taoyuan, Taiwan, 333
United Kingdom
Bebington, United Kingdom, CH63 4JY
London, United Kingdom, SE5 9RS
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01507168     History of Changes
Other Study ID Numbers: NP27884, 2011-003574-84
Study First Received: January 6, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014