Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of GC33 (RO5137382) 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.
 
ClinicalTrials.gov Identifier: NCT01507168
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 6, 2012
First Posted Date  ICMJE January 10, 2012
Last Update Posted Date April 3, 2020
Actual Study Start Date  ICMJE February 2, 2012
Actual Primary Completion Date August 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
  • Overall survival [ Time Frame: approximately 32 months ]
  • Time to progression (TTP): Time from randomization to first documented disease progression [ Time Frame: approximately 24 months ]
  • Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks [ Time Frame: approximately 24 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 months ]
  • 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 ]
  • GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay [ Time Frame: at screening ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Official Title  ICMJE 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)
Brief Summary This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: Placebo
    iv Days 1 and 8, and every 2 weeks thereafter
  • Drug: GC33
    1600 mg iv Day 1 and 8, and every 2 weeks thereafter
    Other Name: RO5137382
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: GC33 (RO5137382)
    Intervention: Drug: GC33
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2020)
185
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2012)
156
Actual Study Completion Date  ICMJE August 20, 2015
Actual Primary Completion Date August 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01507168
Other Study ID Numbers  ICMJE NP27884
2011-003574-84 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP