Carcinoma, HepatocellularPhase 2NCT00044512
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 23 sites in 5 countries.
Trial summary
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven 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?
- Sorafenib (Nexavar, BAY43-9006)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Aug 2002to Feb 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
- Measurable disease
- At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Presence of at least 1 of the following:
- Alpha-fetoprotein greater than the upper limit of normal (ULN)
Show all 10Show fewer
- Hepatitis C antibody positive
- Hepatitis B surface antigen positive
- Child's Pugh class A or B
- Candidate for systemic therapy
Who cannot join
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Israel6 sites
Study site
Haifa, Israel, 31096
Study site
Jerusalem, Israel, 91120
Study site
Petah Tikva, Israel, 49100
Study site
Rehovot, Israel, 76100
Study site
Tel Aviv, Israel, 64239
Study site
Tel Litwinsky, 52621
Belgium5 sites
Study site
Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1070
Study site
Bruxelles - Brussel, 1090
Study site
Ghent, 9000
Study site
Leuven, 3000
France5 sites
Study site
Lille, 59020
Study site
Marseille, 13005
Study site
Paris, 75020
Study site
Rennes, 35062
Study site
Saint-Herblain, 44805
Italy5 sites
Study site
Forlì, 47100
Study site
Milan, 20122
Study site
Pisa, 56126
Study site
Rozzano, Milano, 20089
Study site
Verona, 37126
United States2 sites
Study site
Los Angeles, California, 90057
Study site
New York, New York, 10021-6007
About this study
Official title: A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
Read the detailed description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
- Pharmacokinetics (PK) profile of Sorafenib
- Plasma and tissue tumor biomarkers
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Cancer, Liver Cancer, Hepatocellular carcinoma (HCC)
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib 400 mg b.i.d. | Experimental | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants for Each Type of Response
Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.
Measured: Until 30 days after termination of active therapy
Secondary outcomes (7)
Duration of Response
Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
Measured: up to 3 years later
Time to Response
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
Measured: up to 3 years later
Time to Progression
Time from the first date of receiving study drug until the first documented PD.
Measured: up to 3 years later
Duration of Stable Disease
Time from the first day of receiving study drug until there was a documented PD or response.
Measured: up to 3 years later
Time to Minor Response
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
Measured: up to 3 years later
Duration of Minor Response
Time from the date that MR was first documented to the date that PD was first documented.
Measured: Time from MR to PD
Overall Survival
Time from the first date of receiving study medication to death.
Measured: Start of treatment to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2002 (estimated)
- Study startAug 2002
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 BayerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044512
- Sponsor's protocol ID
- 10874
- Status last verified
- Mar 2014
- First submitted
- 30 Aug 2002
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
PubMed 16908937Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4.
PubMed 21673874
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00044512
- Acronym / sponsor ID
- 10874
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Cancer, Liver Cancer, Hepatocellular carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 4 Sep 2002 (estimated)
- Results
- Posted 6 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
Detailed description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
- Pharmacokinetics (PK) profile of Sorafenib
- Plasma and tissue tumor biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib 400 mg b.i.d. | Experimental | Drug: Sorafenib (Nexavar, BAY43-9006)Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
- Measurable disease
- At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Presence of at least 1 of the following:
Key exclusion criteria (2 listed)
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
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 |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) | Drug | Sorafenib 400 mg b.i.d. |
Primary outcome
Percentage of Participants for Each Type of Response
Time frame: Until 30 days after termination of active therapy
Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.
7 secondary outcomes
Duration of Response
Time frame: up to 3 years later
Time to Response
Time frame: up to 3 years later
Time to Progression
Time frame: up to 3 years later
Duration of Stable Disease
Time frame: up to 3 years later
Time to Minor Response
Time frame: up to 3 years later
Duration of Minor Response
Time frame: Time from MR to PD
Overall Survival
Time frame: Start of treatment to death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16908937Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
- Results publication: PubMed 21673874Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4.
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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.
Bayer Study Director study director
Bayer
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 23 sites in 5 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 10 inclusion and 2 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Israel, Belgium, France, Italy, United States. 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 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?
Yes. Results are posted in the registry (first posted 6 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants for Each Type of Response (time frame: Until 30 days after termination of active therapy). 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 NCT00044512, 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 16 Apr 2014; AzTrials last refreshed its copy on 26 Oct 2026.