Carcinoma, Non Small Cell LungPhase 2NCT00160069
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
A Phase 2 study testing Sagopilone (BAY86-5302, ZK 219477) in people with Carcinoma, Non Small Cell Lung, run by Bayer at 17 sites in Germany.
Trial summary
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- Sagopilone (BAY86-5302, ZK 219477)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 17 sitesGermany
- Study dates
- Aug 2005to Apr 2009
- 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
- Non-small-cell lung cancer
- Only one previous chemotherapy with a platinum-containing drug
- Use of highly effective birth control methods in females of child-bearing potential
Who cannot join
- No more than 1 previous chemotherapy for advanced disease
- Previous participation in another trial within the last 4 weeks
- Breast feeding
- Active infections
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
Study site
Augsburg, Bavaria, 86156
Study site
Berlin, State of Berlin, 12200
Study site
Berlin, State of Berlin, 14165
Study site
Bremen, 29325
Study site
Ebensfeld, 96250
Study site
Frankfurt am Main, Hesse, 60590
Study site
Frankfurt am Main, Hesse, 65929
Study site
Gauting, Bavaria, 82131
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
Study site
Großhansdorf, Schleswig-Holstein, 22927
Study site
Halle, Saxony-Anhalt, 06120
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21075
Study site
Leipzig, Saxony, 04103
Study site
Löwenstein, Baden-Wurttemberg, 74245
Study site
Magdeburg, Saxony-Anhalt, 39130
Study site
Nuremberg, Bavaria, 90419
Study site
Stralsund, Mecklenburg-Vorpommern, 17475
About this study
Official title: Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- Sagopilone (BAY86-5302, ZK 219477)
- Keywords
- Stage IIIB or stage IV non-small-cell lung cancer.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone (BAY86-5302, ZK 219477)Drug
16 mg/m2, 3-hour infusion, every 3 weeks
Sagopilone (BAY86-5302, ZK 219477)Drug
22 mg/m2, 30-min infusion, every 3 weeks
Sagopilone (BAY86-5302, ZK 219477)Drug
22 mg/m2, 3-hour infusion, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 2 | Experimental | Not described Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 3 | Experimental | Not described Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Measured: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Secondary outcomes (1)
Secondary objectives : investigate the safety and tolerability of ZK 219477
Measured: Continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2008
- Study completionApr 2009
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, Non Small Cell LungStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 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
- NCT00160069
- Sponsor's protocol ID
- 91374
- Other IDs
- 2005-000586-19, 307971, 2005
- Status last verified
- Dec 2014
- First submitted
- 8 Sep 2005
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.
PubMed 23522488
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00160069
- Acronym / sponsor ID
- 91374
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- Stage IIIB or stage IV non-small-cell lung cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Sep 2005 (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.
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 2 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 3 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-small-cell lung cancer
- Only one previous chemotherapy with a platinum-containing drug
- Use of highly effective birth control methods in females of child-bearing potential
Key exclusion criteria (4 listed)
- No more than 1 previous chemotherapy for advanced disease
- Previous participation in another trial within the last 4 weeks
- Breast feeding
- Active infections
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 |
|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477)16 mg/m2, 3-hour infusion, every 3 weeks | Drug | Arm 1 |
| Sagopilone (BAY86-5302, ZK 219477)22 mg/m2, 30-min infusion, every 3 weeks | Drug | Arm 2 |
| Sagopilone (BAY86-5302, ZK 219477)22 mg/m2, 3-hour infusion, every 3 weeks | Drug | Arm 3 |
Primary outcome
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Time frame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
1 secondary outcome
Secondary objectives : investigate the safety and tolerability of ZK 219477
Time frame: Continuously
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 4 Dec 2014.
- Results publication: PubMed 23522488Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.
- Click here and search for Bayer product information provided by the EMALink 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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sagopilone (BAY86-5302, ZK 219477) in people with Carcinoma, Non Small Cell Lung, run by Bayer at 17 sites in Germany.
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 3 inclusion and 4 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 4 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 17 sites in Germany. 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?
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria. (time frame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.). 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 NCT00160069, 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 4 Dec 2014.