Carcinoma, Renal CellPhase 3NCT00492986
An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell Carcinoma
A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 33 sites in 11 countries.
Trial summary
Purpose of the study: The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 33 sitesin 11 countries
- Study dates
- Oct 2005to Nov 2008
- Phase
- Phase 3
- 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
- The patient must provide written informed consent prior to receiving BAY 43-9006
- The male or female patient must be at least 18 years of age
- The patient must have advanced Renal Cell Carcinoma
- The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC
- A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry
- The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent
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- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates while taking BAY 43-9006
- Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with sorafenib
- For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks)
Who cannot join
- Patients who are currently enrolled in or have previously participated in any other sorafenib trial
- Patients, who are eligible for or do have access to any other sorafenib clinical trial as to the knowledge of the Investigator
- Patients who have a life expectancy of less than 2 months
- Patients with metastatic brain or meningeal tumors
- Patients are excluded who require any of the following:
- Investigational drug therapy during the treatment with sorafenib or within 30 days prior to their first dose of sorafenib
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- Concomitant Rifampicin
- Concomitant St. John's Wort (Hypericum perforatum) Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time (PT) should be performed (please note that no laboratory data are collected in this study)
- Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study)
- Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
- Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45-0.47 second)
- Patients with active coronary artery disease or ischemia
- Patients with Child-Pugh class C hepatic impairment
- Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis
- Patients with active uncontrolled hypertension
- Patients with recent or active bleeding diathesis
- Patients with any medical condition which could jeopardize their safety while taking an investigational drug
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
Germany10 sites
Study site
Berlin, State of Berlin, 12200
Study site
Darmstadt, Hesse, 64276
Study site
Dresden, Saxony, 01307
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20251
Study site
Homburg, Saarland, 66421
Study site
Koblenz, Rhineland-Palatinate, 56068
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
München, Bavaria, 81377
Italy5 sites
Study site
Milan, 20133
Study site
Modena, 41124
Study site
Pavia, 27100
Study site
Perugia, 06156
Study site
Reggio Emilia, 42100
France3 sites
Study site
Bordeaux, 33000
Study site
Lyon, 69008
Study site
Villejuif, 94805
Spain3 sites
Study site
Barcelona, Barcelona, 08035
Study site
Madrid, Madrid, 28040
Study site
Oviedo, Principality of Asturias, 33006
United Kingdom3 sites
Study site
Glasgow, Stratchclyde, G11 6NT
Study site
London, London, SW3 6JJ
Study site
Sutton, Surrey, SM2 5PT
Switzerland2 sites
Study site
Basel, Canton of Basel-City, 4031
Study site
Geneva, Canton of Geneva, 1211
About this study
Official title: An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma
Purpose of the study:
The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.
Read more
Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.
Overall, participation in the study will help determine the following:
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib helps to slow the worsening of kidney cancer
- Find out if Sorafenib has an effect on the tumours
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Nexavar (Sorafenib, BAY43-9006)
- Keywords
- Renal Cell Cancer (RCC), Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib, BAY43-9006)Drug
Multikinase inhibitor: Sorafenib mono therapy 400 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Parameters
Measured: Continously
Secondary outcomes (1)
Collection of radiological evaluations
Measured: Continously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startOct 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,150 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
- NCT00492986
- Sponsor's protocol ID
- 11941
- Other IDs
- 2005-002524-34, 2005
- Status last verified
- Dec 2014
- First submitted
- 26 Jun 2007
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00492986
- Acronym / sponsor ID
- 11941
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal Cell Cancer (RCC), Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Jun 2007 (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.
Purpose of the study:
The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.
Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.
Overall, participation in the study will help determine the following:
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib helps to slow the worsening of kidney cancer
- Find out if Sorafenib has an effect on the tumours
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient must provide written informed consent prior to receiving BAY 43-9006
- The male or female patient must be at least 18 years of age
- The patient must have advanced Renal Cell Carcinoma
- The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC
- A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry
Key exclusion criteria (17 listed)
- Patients who are currently enrolled in or have previously participated in any other sorafenib trial
- Patients, who are eligible for or do have access to any other sorafenib clinical trial as to the knowledge of the Investigator
- Patients who have a life expectancy of less than 2 months
- Patients with metastatic brain or meningeal tumors
- Patients are excluded who require any of the following:
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 |
|---|---|---|
| Nexavar (Sorafenib, BAY43-9006)Multikinase inhibitor: Sorafenib mono therapy 400 mg bid | Drug | Arm 1 |
Primary outcome
Safety Parameters
Time frame: Continously
1 secondary outcome
Collection of radiological evaluations
Time frame: Continously
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 30 Dec 2014.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 33 sites in 11 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 17 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Italy, France, Spain, United Kingdom and 6 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety Parameters (time frame: Continously). 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 30 Dec 2014.