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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01507168




Registration number
NCT01507168
Ethics application status
Date submitted
6/01/2012
Date registered
10/01/2012
Date last updated
3/04/2020

Titles & IDs
Public title
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Scientific 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)
Secondary ID [1] 0 0
2011-003574-84
Secondary ID [2] 0 0
NP27884
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - GC33

Placebo comparator: Placebo -

Experimental: GC33 (RO5137382) -


Treatment: Drugs: Placebo
iv Days 1 and 8, and every 2 weeks thereafter

Treatment: Drugs: GC33
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (tumor assessments according to RECIST criteria)
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
approximately 32 months
Secondary outcome [2] 0 0
Time to progression (TTP): Time from randomization to first documented disease progression
Timepoint [2] 0 0
approximately 24 months
Secondary outcome [3] 0 0
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Timepoint [3] 0 0
approximately 24 months
Secondary outcome [4] 0 0
Safety: Incidence of adverse events
Timepoint [4] 0 0
approximately 24 months
Secondary outcome [5] 0 0
Pharmacokinetics: Serum concentrations (Cmax,Cmin)
Timepoint [5] 0 0
Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11
Secondary outcome [6] 0 0
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
Timepoint [6] 0 0
at screening

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2015
Sample size
Target
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
France
State/province [10] 0 0
Angers
Country [11] 0 0
France
State/province [11] 0 0
Grenoble
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
France
State/province [16] 0 0
Vandoeuvre-les-nancy
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt Am Main
Country [19] 0 0
Germany
State/province [19] 0 0
Heidelberg
Country [20] 0 0
Germany
State/province [20] 0 0
Leipzig
Country [21] 0 0
Germany
State/province [21] 0 0
Muenchen
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Pokfulam
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Shatin
Country [24] 0 0
Italy
State/province [24] 0 0
Campania
Country [25] 0 0
Italy
State/province [25] 0 0
Lazio
Country [26] 0 0
Italy
State/province [26] 0 0
Lombardia
Country [27] 0 0
Japan
State/province [27] 0 0
Chiba
Country [28] 0 0
Japan
State/province [28] 0 0
Ishikawa
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Busan
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggi-do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
Singapore
State/province [36] 0 0
Singapore
Country [37] 0 0
Spain
State/province [37] 0 0
Cantabria
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Zaragoza
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei City
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Bebington
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01507168