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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01507168
Ethics application status
Date submitted
6/01/2012
Date registered
10/01/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of RO5137382 (GC33) 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 - RO5137382

Placebo Comparator: Placebo -

Experimental: RO5137382 (GC33) -


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

Treatment: Drugs: RO5137382
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
France
State/province [11] 0 0
Angers
Country [12] 0 0
France
State/province [12] 0 0
Clichy
Country [13] 0 0
France
State/province [13] 0 0
Grenoble
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
France
State/province [18] 0 0
Vandoeuvre-les-nancy
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Frankfurt Am Main
Country [22] 0 0
Germany
State/province [22] 0 0
Freiburg
Country [23] 0 0
Germany
State/province [23] 0 0
Heidelberg
Country [24] 0 0
Germany
State/province [24] 0 0
Leipzig
Country [25] 0 0
Germany
State/province [25] 0 0
Munich
Country [26] 0 0
Germany
State/province [26] 0 0
Tübingen
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Pokfulam
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Shatin
Country [29] 0 0
Italy
State/province [29] 0 0
Campania
Country [30] 0 0
Italy
State/province [30] 0 0
Lazio
Country [31] 0 0
Italy
State/province [31] 0 0
Lombardia
Country [32] 0 0
Italy
State/province [32] 0 0
Veneto
Country [33] 0 0
Japan
State/province [33] 0 0
Chiba
Country [34] 0 0
Japan
State/province [34] 0 0
Ishikawa
Country [35] 0 0
Japan
State/province [35] 0 0
Kanagawa
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Gyeonggi-do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore
Country [43] 0 0
Spain
State/province [43] 0 0
Cantabria
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Zaragoza
Country [47] 0 0
Taiwan
State/province [47] 0 0
Kaohsiung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taichung
Country [49] 0 0
Taiwan
State/province [49] 0 0
Tainan
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taipei
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taoyuan
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Bebington
Country [53] 0 0
United Kingdom
State/province [53] 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
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.
Trial website
https://clinicaltrials.gov/show/NCT01507168
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

Summary results
Other publications