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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01507168
First received: January 6, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 177
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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
Other Name: GC33
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507168

Contacts
Contact: Please reference Study ID Number: NP27884 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 66 Study Locations
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: May 7, 2013
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 May 16, 2013