Hepatocellular CarcinomaPhase 1NCT00956436
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
A Phase 1 study testing BIIB022 and Sorafenib in people with Hepatocellular Carcinoma, run by Biogen at 11 sites in 4 countries.
Trial summary
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- BIIB022 and Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Aug 2009to Apr 2011
- Phase
- Phase 1
- 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
- Age ≥18 years
- Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
- Child-Pugh score A5 or A6.
- ECOG Performance Status of ≤2.
Who cannot join
- Known central nervous system or brain metastases.
- Prior anti-IGF-1R therapy.
- Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
- Concurrent anticancer therapy.
- History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
- Acute hepatitis
- Fibrolamellar HCC
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States6 sites
Resesarch Site
Boston, Massachusetts
Resesarch Site
Denver, Colorado
Resesarch Site
Indianapolis, Indiana
Resesarch Site
New York, New York
Resesarch Site
Norfolk, Virginia
Resesarch Site
Ocoee, Florida
About this study
Official title: A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- BIIB022, Sorafenib
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R, Nexavar
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Insulin-Like Growth Factor I, Resistance To
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB022Drug
Also called IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal Antibody
IV Q3W
SorafenibDrug
Also called HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver Cancer
Standard dosing of Sorafenib
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib Monotherapy | Experimental | Sorafenib Monotherapy Receives: Drug: Sorafenib |
| Sorafenib with BIIB022 | Experimental | Sorafenib with BIIB022 Receives: Drug: BIIB022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Measured: 6 months
Secondary outcomes (2)
To evaluate the PK profile of BIIB022 and sorafenib in this study population
Measured: 6 months
To assess the anti-tumor response in this study population
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BiogenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956436
- Sponsor's protocol ID
- 212HC201
- Status last verified
- Nov 2011
- First submitted
- 5 Aug 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00956436
- Acronym / sponsor ID
- 212HC201
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R, Nexavar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Aug 2009 (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 is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib Monotherapy | Experimental | Drug: SorafenibSorafenib Monotherapy |
| Sorafenib with BIIB022 | Experimental | Drug: BIIB022Sorafenib with BIIB022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
- Child-Pugh score A5 or A6.
- ECOG Performance Status of ≤2.
Key exclusion criteria (8 listed)
- Known central nervous system or brain metastases.
- Prior anti-IGF-1R therapy.
- Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
- Concurrent anticancer therapy.
- History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
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 |
|---|---|---|
| BIIB022Also: IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal AntibodyIV Q3W | Drug | Sorafenib with BIIB022 |
| SorafenibAlso: HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver CancerStandard dosing of Sorafenib | Drug | Sorafenib Monotherapy |
Primary outcome
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Time frame: 6 months
2 secondary outcomes
To evaluate the PK profile of BIIB022 and sorafenib in this study population
Time frame: 6 months
To assess the anti-tumor response in this study population
Time frame: 6 months
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 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB022 and Sorafenib in people with Hepatocellular Carcinoma, run by Biogen at 11 sites in 4 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 4 inclusion and 8 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Taiwan, Singapore, United Kingdom. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2013.