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

January 6, 2012
July 7, 2014
February 2012
April 2014   (final data collection date for primary outcome measure)
Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01507168 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5137382 (GC33) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Liver Cancer
  • Drug: RO5137382
    1600 mg iv Day 1 and 8, and every 2 weeks thereafter
  • Drug: Placebo
    iv Days 1 and 8, and every 2 weeks thereafter
  • Experimental: RO5137382 (GC33)
    Intervention: Drug: RO5137382
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
April 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   United States,   Belgium,   France,   Germany,   Hong Kong,   Italy,   Japan,   United Kingdom,   New Zealand,   Singapore,   Spain,   Taiwan
 
NCT01507168
NP27884, 2011-003574-84
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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