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Completed

NCT Number: NCT01507168

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

iv Days 1 and 8, and every 2 weeks thereafter

GC33

Drug

1600 mg iv Day 1 and 8, and every 2 weeks thereafter

Other names: RO5137382

Primary outcomes

  1. Progression-free survival (tumor assessments according to RECIST criteria)

    Time frame: approximately 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 10, 2012
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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