Carcinoma, HepatocellularPhase 2NCT01507168
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
A Phase 2 study testing GC33 in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 57 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- GC33
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 2 Feb 2012to 20 Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States8 sites
National Cancer Institute; Ctr for Cancer Research
Bethesda, Maryland, 20889-0001
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
UCLA Medical Center
Los Angeles, California, 90095
Vanderbilt Medical Center
Nashville, Tennessee, 37232-7610
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Swedish Cancer Inst.
Seattle, Washington, 98104
Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center
St Louis, Missouri, 63110
Spain8 sites
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
Barcelona, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, 50009
France7 sites
Hotel Dieu; Medecine A
Angers, 49033
CHU de GRENOBLE; UF de Cancérologie
Grenoble, 38 043
Aphm; Hopital De La Conception
Marseille, 13385
Hopital de L'Archet; Pole de Reference Hepatite C
Nice, 06202
Hôpital Saint Antoine; Service Hépathologie
Paris, 75571
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, 31059
Hôpital d'Adultes; Service hépato-gastro-entérologie
Vandœuvre-lès-Nancy, 54511
Japan6 sites
National Cancer Center Hospital East
Chiba, 277-8577
Kanazawa University Hospital
Ishikawa, 920-8641
Kanagawa Cancer Center
Kanagawa, 241-8515
Kindai University Hospital
Osaka, 589-8511
National Cancer Center Hospital
Tokyo, 104-0045
Kyorin University Hospital
Tokyo, 181-8611
South Korea6 sites
Pusan University Hospital
Busan, 602-739
National Cancer Center
Gyeonggi-do, 10408
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul St Mary's Hospital
Seoul, 06591
Germany5 sites
Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie
Berlin, 13353
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt am Main, 60590
Uni Heidelberg Med. Klinik; Innere Medizin IV
Heidelberg, 69120
Universitätsklinikum Leipzig
Leipzig, 04103
Klinikum rechts der Isar der TU München; Klinikapotheke
München, 81675
Taiwan5 sites
Chang Gung Memorial Foundation - Kaohsiung
Kaohsiung City, 00833
Taichung Veterans Gen Hosp
Taichung, 40705
National Cheng Kung Univ Hosp
Tainan, 00704
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100
Taipei Veterans General Hospital
Taipei, 112
Italy3 sites
Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1
Benevento, Campania, 82100
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, 20122
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
United Kingdom3 sites
The Clatterbridge Cancer Ctr NHS Foundation Trust
Bebington, CH63 4JY
Royal Free Hospital; Dept of Oncology
London, NW3 2QG
King'S College Hospital; Haematology
London, SE5 9RS
Hong Kong2 sites
Queen Mary Hospital; Dept of Surgery
Pokfulam
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin
New Zealand1 site
Auckland Hospital; New Zealand Liver Transplant Unit
Auckland, 100
About this study
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)
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Placebo, GC33
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
iv Days 1 and 8, and every 2 weeks thereafter
GC33Drug
Also called RO5137382
1600 mg iv Day 1 and 8, and every 2 weeks thereafter
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| GC33 (RO5137382) | Experimental | Not described Receives: Drug: GC33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (tumor assessments according to RECIST criteria)
Measured: approximately 24 months
Secondary outcomes (6)
Overall survival
Measured: approximately 32 months
Time to progression (TTP): Time from randomization to first documented disease progression
Measured: approximately 24 months
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Measured: approximately 24 months
Safety: Incidence of adverse events
Measured: approximately 24 months
Pharmacokinetics: Serum concentrations (Cmax,Cmin)
Measured: Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
Measured: at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study start2 Feb 2012
- Primary completion20 Aug 2015
- Study completion20 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507168
- Sponsor's protocol ID
- NP27884
- Other IDs
- 2011-003574-84
- Status last verified
- Apr 2020
- First submitted
- 6 Jan 2012
- Last updated
- 3 Apr 2020
- Results posted
- No
Publications
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.
PubMed 30922327Abou-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.
PubMed 27085251
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01507168
- Acronym / sponsor ID
- NP27884
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2012 (actual)
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 20 Aug 2015 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| GC33 (RO5137382) | Experimental | Drug: GC33 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboiv Days 1 and 8, and every 2 weeks thereafter | Drug | Placebo |
| GC33Also: RO51373821600 mg iv Day 1 and 8, and every 2 weeks thereafter | Drug | GC33 (RO5137382) |
Primary outcome
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: approximately 24 months
6 secondary outcomes
Overall survival
Time frame: approximately 32 months
Time to progression (TTP): Time from randomization to first documented disease progression
Time frame: approximately 24 months
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Time frame: approximately 24 months
Safety: Incidence of adverse events
Time frame: approximately 24 months
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
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
Time frame: at screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 30922327Pradier 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.
- Derived from this study: PubMed 27085251Abou-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC33 in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 57 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Spain, France, Japan, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (tumor assessments according to RECIST criteria) (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.