Breast NeoplasmsPhase 2NCT00288249
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer
A Phase 2 study testing Sagopilone (BAY86-5302, ZK 219477) in people with Breast Neoplasms and Breast Cancer, Metastatic, run by Bayer at 21 sites in 10 countries.
Trial summary
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer, Metastatic
- 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
- 82 participants
- Where
- 21 sitesin 10 countries
- Study dates
- Dec 2005to Jan 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic breast cancer
- No previous treatment with taxanes, and vinca alkaloids
- Use of highly effective birth control methods in females of child-bearing potential
Who cannot join
- More than 2 previous chemotherapies
- Previous participation in another trial within the last 4 weeks
- Breast feeding
- Active infections
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
France5 sites
Study site
Angers, 49033
Study site
Bordeaux, 33076
Study site
Clermont-Ferrand, 63011
Study site
Saint-Herblain, 44805
Study site
Vandœuvre-lès-Nancy, France, 54500
Bulgaria3 sites
Study site
Plovdiv, 4001
Study site
Sofia, 01784
Study site
Varna, 9000
Italy3 sites
Study site
Forlì, FC, 47100
Study site
Milan, MI, 20162
Study site
Reggio Emilia, RE, 42100
Austria2 sites
Study site
Vienna, State of Vienna, 1090
Study site
Vienna, State of Vienna, 1100
United Kingdom1 site
Study site
Manchester, Greater Manchester, M20 4BX
About this study
Official title: Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast 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
- Breast Neoplasms, Breast Cancer, Metastatic
- Being tested
- Sagopilone (BAY86-5302, ZK 219477)
- Keywords
- Breast Cancer, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
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 i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)Drug
12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)Drug
22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)Drug
22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 3 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 4 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
| Arm 1 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) Receives: Drug: Sagopilone (BAY86-5302, ZK 219477) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (complete or partial response according to RECIST)
The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).
Measured: Every 6 weeks
Secondary outcomes (2)
Duration of complete or partial tumor response
Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented
Measured: Every 6 weeks
Time to tumor progression
Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMar 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT00288249
- Sponsor's protocol ID
- 91464
- Other IDs
- 2005-003216-30, 309544, 2005
- Status last verified
- Nov 2014
- First submitted
- 6 Feb 2006
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00288249
- Acronym / sponsor ID
- 91464
- Conditions
- Breast Neoplasms, Breast Cancer, Metastatic
- Keywords
- Breast Cancer, Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Feb 2006 (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 the study drug is effective and safe in the treatment of patients with metastatic breast 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477)Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
| Arm 3 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477)Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
| Arm 4 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477)Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
| Arm 1 | Experimental | Drug: Sagopilone (BAY86-5302, ZK 219477)Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Metastatic breast cancer
- No previous treatment with taxanes, and vinca alkaloids
- Use of highly effective birth control methods in females of child-bearing potential
Key exclusion criteria (4 listed)
- More than 2 previous chemotherapies
- 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 i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. | Drug | Arm 1 |
| Sagopilone (BAY86-5302, ZK 219477)12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. | Drug | Arm 2 |
| Sagopilone (BAY86-5302, ZK 219477)22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. | Drug | Arm 3 |
| Sagopilone (BAY86-5302, ZK 219477)22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. | Drug | Arm 4 |
Primary outcome
Tumor response rate (complete or partial response according to RECIST)
Time frame: Every 6 weeks
The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).
2 secondary outcomes
Duration of complete or partial tumor response
Time frame: Every 6 weeks
Time to tumor progression
Time frame: Every 6 weeks
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 2 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
21 sites in 10 countries: 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 Breast Neoplasms and Breast Cancer, Metastatic, run by Bayer at 21 sites in 10 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 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 2 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 21 sites in France, Bulgaria, Italy, Austria, Poland and 5 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 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?
Tumor response rate (complete or partial response according to RECIST) (time frame: Every 6 weeks). 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 2 Dec 2014.