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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01507168
Collaborator
(none)
185
Enrollment
57
Locations
2
Arms
42.5
Actual Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
185 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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)
Actual Study Start Date :
Feb 2, 2012
Actual Primary Completion Date :
Aug 20, 2015
Actual Study Completion Date :
Aug 20, 2015

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
iv Days 1 and 8, and every 2 weeks thereafter
Experimental: GC33 (RO5137382)

Drug: GC33
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Other Names:
  • RO5137382

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (tumor assessments according to RECIST criteria) [approximately 24 months]

    Secondary Outcome Measures

    1. Overall survival [approximately 32 months]

    2. Time to progression (TTP): Time from randomization to first documented disease progression [approximately 24 months]

    3. Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks [approximately 24 months]

    4. Safety: Incidence of adverse events [approximately 24 months]

    5. Pharmacokinetics: Serum concentrations (Cmax,Cmin) [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 [at screening]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UCLA Medical Center Los Angeles California United States 90095
    2 National Cancer Institute; Ctr for Cancer Research Bethesda Maryland United States 20889-0001
    3 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    4 Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center Saint Louis Missouri United States 63110
    5 Columbia University Medical Center New York New York United States 10032
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Vanderbilt Medical Center Nashville Tennessee United States 37232-7610
    8 Swedish Cancer Inst. Seattle Washington United States 98104
    9 Hospital Erasme Bruxelles Belgium 1070
    10 UZ Gent Gent Belgium 9000
    11 Hotel Dieu; Medecine A Angers France 49033
    12 CHU de GRENOBLE; UF de Cancérologie Grenoble France 38 043
    13 Aphm; Hopital De La Conception Marseille France 13385
    14 Hopital de L'Archet; Pole de Reference Hepatite C Nice France 06202
    15 Hôpital Saint Antoine; Service Hépathologie Paris France 75571
    16 Hopital Purpan;Gastro Enterologie Hepatologie Toulouse France 31059
    17 Hôpital d'Adultes; Service hépato-gastro-entérologie Vandoeuvre-les-nancy France 54511
    18 Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie Berlin Germany 13353
    19 Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I Frankfurt Am Main Germany 60590
    20 Uni Heidelberg Med. Klinik; Innere Medizin IV Heidelberg Germany 69120
    21 Universitätsklinikum Leipzig Leipzig Germany 04103
    22 Klinikum rechts der Isar der TU München; Klinikapotheke Muenchen Germany 81675
    23 Queen Mary Hospital; Dept of Surgery Pokfulam Hong Kong
    24 Prince of Wales Hosp; Dept. Of Clinical Onc Shatin Hong Kong
    25 Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1 Benevento Campania Italy 82100
    26 Policlinico Universitario Agostino Gemelli Roma Lazio Italy 00168
    27 Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia Milano Lombardia Italy 20122
    28 National Cancer Center Hospital East Chiba Japan 277-8577
    29 Kanazawa University Hospital Ishikawa Japan 920-8641
    30 Kanagawa Cancer Center Kanagawa Japan 241-8515
    31 Kindai University Hospital Osaka Japan 589-8511
    32 National Cancer Center Hospital Tokyo Japan 104-0045
    33 Kyorin University Hospital Tokyo Japan 181-8611
    34 Pusan University Hospital Busan Korea, Republic of 602-739
    35 National Cancer Center Gyeonggi-do Korea, Republic of 10408
    36 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    37 Asan Medical Center Seoul Korea, Republic of 05505
    38 Samsung Medical Center Seoul Korea, Republic of 06351
    39 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
    40 Auckland Hospital; New Zealand Liver Transplant Unit Auckland New Zealand 100
    41 National Cancer Centre; Medical Oncology Singapore Singapore 169610
    42 Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Santander Cantabria Spain 39008
    43 Hospital Universitari Vall d'Hebron; Servicio de Hepatologia Barcelona Spain 08035
    44 Hospital Clínic i Provincial; Servicio de Hematología y Oncología Barcelona Spain 08036
    45 Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid Spain 28007
    46 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    47 Hospital Universitario Clínico San Carlos; Servicio de Oncologia Madrid Spain 28040
    48 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
    49 Hospital Universitario Miguel Servet; Servicio Hematologia Zaragoza Spain 50009
    50 Chang Gung Memorial Foundation - Kaohsiung Kaohsiung Taiwan 00833
    51 Taichung Veterans Gen Hosp Taichung Taiwan 40705
    52 National Cheng Kung Univ Hosp Tainan Taiwan 00704
    53 Taipei Veterans General Hospital Taipei City Taiwan 112
    54 National Taiwan Uni Hospital; Dept of Oncology Taipei Taiwan 100
    55 The Clatterbridge Cancer Ctr NHS Foundation Trust Bebington United Kingdom CH63 4JY
    56 Royal Free Hospital; Dept of Oncology London United Kingdom NW3 2QG
    57 King'S College Hospital; Haematology London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01507168
    Other Study ID Numbers:
    • NP27884
    • 2011-003574-84
    First Posted:
    Jan 10, 2012
    Last Update Posted:
    Apr 3, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Apr 3, 2020