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

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
GC33
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA Medical Center
  • National Cancer Institute; Ctr for Cancer Research
  • Barbara Ann Karmanos Cancer Institute
  • Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center
  • Columbia University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Vanderbilt Medical Center
  • Swedish Cancer Inst.
  • Hospital Erasme
  • UZ Gent
  • Hotel Dieu; Medecine A
  • CHU de GRENOBLE; UF de Cancérologie
  • Aphm; Hopital De La Conception
  • Hopital de L'Archet; Pole de Reference Hepatite C
  • Hôpital Saint Antoine; Service Hépathologie
  • Hopital Purpan;Gastro Enterologie Hepatologie
  • Hôpital d'Adultes; Service hépato-gastro-entérologie
  • Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
  • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
  • Uni Heidelberg Med. Klinik; Innere Medizin IV
  • Universitätsklinikum Leipzig
  • Klinikum rechts der Isar der TU München; Klinikapotheke
  • Queen Mary Hospital; Dept of Surgery
  • Prince of Wales Hosp; Dept. Of Clinical Onc
  • Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1
  • Policlinico Universitario Agostino Gemelli
  • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
  • National Cancer Center Hospital East
  • Kanazawa University Hospital
  • Kanagawa Cancer Center
  • Kindai University Hospital
  • National Cancer Center Hospital
  • Kyorin University Hospital
  • Pusan University Hospital
  • National Cancer Center
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul St Mary's Hospital
  • Auckland Hospital; New Zealand Liver Transplant Unit
  • National Cancer Centre; Medical Oncology
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio Hematologia
  • Chang Gung Memorial Foundation - Kaohsiung
  • Taichung Veterans Gen Hosp
  • National Cheng Kung Univ Hosp
  • Taipei Veterans General Hospital
  • National Taiwan Uni Hospital; Dept of Oncology
  • The Clatterbridge Cancer Ctr NHS Foundation Trust
  • Royal Free Hospital; Dept of Oncology
  • King'S College Hospital; Haematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

GC33 (RO5137382)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival
Time to progression (TTP): Time from randomization to first documented disease progression
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Safety: Incidence of adverse events
Pharmacokinetics: Serum concentrations (Cmax,Cmin)
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay

Full Information

First Posted
January 6, 2012
Last Updated
April 1, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01507168
Brief Title
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2012 (Actual)
Primary Completion Date
August 20, 2015 (Actual)
Study Completion Date
August 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
GC33 (RO5137382)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv Days 1 and 8, and every 2 weeks thereafter
Intervention Type
Drug
Intervention Name(s)
GC33
Other Intervention Name(s)
RO5137382
Intervention Description
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Primary Outcome Measure Information:
Title
Progression-free survival (tumor assessments according to RECIST criteria)
Time Frame
approximately 24 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
approximately 32 months
Title
Time to progression (TTP): Time from randomization to first documented disease progression
Time Frame
approximately 24 months
Title
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Time Frame
approximately 24 months
Title
Safety: Incidence of adverse events
Time Frame
approximately 24 months
Title
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
Title
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
Time Frame
at screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
National Cancer Institute; Ctr for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-0001
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7610
Country
United States
Facility Name
Swedish Cancer Inst.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hotel Dieu; Medecine A
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CHU de GRENOBLE; UF de Cancérologie
City
Grenoble
ZIP/Postal Code
38 043
Country
France
Facility Name
Aphm; Hopital De La Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital de L'Archet; Pole de Reference Hepatite C
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint Antoine; Service Hépathologie
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Purpan;Gastro Enterologie Hepatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital d'Adultes; Service hépato-gastro-entérologie
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Uni Heidelberg Med. Klinik; Innere Medizin IV
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Klinikapotheke
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Queen Mary Hospital; Dept of Surgery
City
Pokfulam
Country
Hong Kong
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1
City
Benevento
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Pusan University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Auckland Hospital; New Zealand Liver Transplant Unit
City
Auckland
ZIP/Postal Code
100
Country
New Zealand
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Hematologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chang Gung Memorial Foundation - Kaohsiung
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
Facility Name
Taichung Veterans Gen Hosp
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung Univ Hosp
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Dept of Oncology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
The Clatterbridge Cancer Ctr NHS Foundation Trust
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Royal Free Hospital; Dept of Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King'S College Hospital; Haematology
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30922327
Citation
Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.
Results Reference
derived
PubMed Identifier
27085251
Citation
Abou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.
Results Reference
derived

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

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