Carcinoma, HepatocellularPhase 2NCT01003015
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
A Phase 2 study testing BAY73-4506 in people with Carcinoma, Hepatocellular, run by Bayer at 13 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer. 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?
- BAY73-4506
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Sep 2009to Mar 2013
- 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
- Male or female patients aged equal or above 18 years.
- BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
- Liver function status Child-Pugh class A.
- Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
- Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY73-4506.
- ECOG PS of 0 or 1.
- Adequate bone marrow, liver and renal function
Who cannot join
- Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
- Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
- Congestive heart failure NYHA>/= class 2
- Unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Germany5 sites
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Frankfurt am Main, Hesse, 60590
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
Regensburg, Bavaria, 93042
Italy5 sites
Study site
Bologna, 40138
Study site
Milan, 20122
Study site
Milan, 20133
Study site
Roma, 00168
Study site
Rozzano, Milano, 20089
About this study
Official title: An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- BAY73-4506
- Keywords
- HCC, Safety, BAY73-4506
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY73-4506Drug
160 mg BAY73-4506
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY73-4506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Collection
Measured: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
Secondary outcomes (6)
Time to progression
Measured: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression
Objective response rate
Measured: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Disease control rate
Measured: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Overall survival
Measured: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Trough concentration of Regorafenib and metabolites (for Europe only)
Measured: Cycle 1 Day 15 and Cycle 2 Day 1
Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)
Measured: Cycle 1 Day 21 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01003015
- Sponsor's protocol ID
- 14596
- Other IDs
- 2009-012570-13, 2009
- Status last verified
- Apr 2015
- First submitted
- 2 Oct 2009
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25.
PubMed 23809766
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT01003015
- Acronym / sponsor ID
- 14596
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, Safety, BAY73-4506
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY73-4506 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged equal or above 18 years.
- BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
- Liver function status Child-Pugh class A.
- Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
- Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY73-4506.
Key exclusion criteria (7 listed)
- Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
- Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
- Congestive heart failure NYHA>/= class 2
- Unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
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 |
|---|---|---|
| BAY73-4506160 mg BAY73-4506 | Drug | Arm 1 |
Primary outcome
Adverse Event Collection
Time frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
6 secondary outcomes
Time to progression
Time frame: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression
Objective response rate
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Disease control rate
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Overall survival
Time frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Trough concentration of Regorafenib and metabolites (for Europe only)
Time frame: Cycle 1 Day 15 and Cycle 2 Day 1
Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)
Time frame: Cycle 1 Day 21 to Day 28
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 2015.
- Results publication: PubMed 23809766Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25.
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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
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY73-4506 in people with Carcinoma, Hepatocellular, run by Bayer at 13 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 7 inclusion and 7 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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Italy, South Korea, Spain. 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?
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?
Adverse Event Collection (time frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration). 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 NCT01003015, which also lists 1 linked publication.
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 2015.