NeoplasmPhase 2NCT00657254
Extension Program for Bay 43-9006
A Phase 2 study testing Nexavar (Sorafenib, BAY43-9006) in people with Neoplasm and Metastasis, run by Bayer at 6 sites in 4 countries.
Trial summary
The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Metastasis
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Dec 2002to Jun 2005
- 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
Inclusion Criteria: - Patients who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment. Exclusion Criteria:- The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Canada2 sites
Study site
Hamilton, Ontario, L8V 5C2
Study site
Toronto, Ontario, M5G 2M9
Germany2 sites
Study site
Essen, North Rhine-Westphalia, 45147
Study site
Herne, North Rhine-Westphalia, 44625
About this study
The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.
- Conditions
- Neoplasm, Metastasis
- Being tested
- Nexavar (Sorafenib, BAY43-9006)
- Keywords
- Extension, Sorafenib, Survival
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib, BAY43-9006)Drug
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.
| 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.
Survival
Measured: Death
Secondary outcomes (5)
Objective Tumour Response Rate
Measured: Number of confirmed partial and complete responses
Overall Response Duration
Measured: Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
Time to Objective Response
Measured: Time from the date of the first intake of sorafenib to the date that objective response is first documented.
Time to Disease Progression
Measured: Time from first intake of sorafenib to disease progression
Safety Parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startDec 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- 9 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
- NCT00657254
- Sponsor's protocol ID
- 10922
- Status last verified
- Dec 2014
- First submitted
- 8 Apr 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Program for Bay 43-9006
- ClinicalTrials.gov ID
- NCT00657254
- Acronym / sponsor ID
- 10922
- Conditions
- Neoplasm, Metastasis
- Keywords
- Extension, Sorafenib, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 14 Apr 2008 (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 study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.
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
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)Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal. | Drug | Arm 1 |
Primary outcome
Survival
Time frame: Death
5 secondary outcomes
Objective Tumour Response Rate
Time frame: Number of confirmed partial and complete responses
Overall Response Duration
Time frame: Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
Time to Objective Response
Time frame: Time from the date of the first intake of sorafenib to the date that objective response is first documented.
Time to Disease Progression
Time frame: Time from first intake of sorafenib to disease progression
Safety Parameters
Time frame: Throughout study
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 23 Dec 2014.
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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
6 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 Nexavar (Sorafenib, BAY43-9006) in people with Neoplasm and Metastasis, run by Bayer at 6 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?
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 23 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 6 sites in Canada, Germany, United States, Belgium. 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?
Survival (time frame: Death). 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 23 Dec 2014.