Breast NeoplasmPhase 2NCT00313248
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
A Phase 2 study testing Sagopilone (ZK 219477) in people with Breast Neoplasm, run by Bayer at 25 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Sagopilone (ZK 219477)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Apr 2006to Nov 2008
- 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 (meaning the cancer has spread beyond its original location)
- At least one measurable lesion by CT or MRI
- Progression of disease following previous therapy for breast cancer
- Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
- Not be pregnant
- Additional criteria to be determined at screening visit.
Who cannot join
- More than 3 previous chemotherapy regimens
- More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
- Prior treatment with epothilones (e.g. Ixabepilone)
- Symptomatic brain metastases
- Additional criteria to be determined at screening visit
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States21 sites
Study site
Anchorage, Alaska, 99508
Study site
Aurora, Colorado, 80010
Study site
Bakersfield, California, 93309
Study site
Baltimore, Maryland, 21204
Study site
Birmingham, Alabama, 35233
Study site
Daytona Beach, Florida, 32114
Study site
Decatur, Illinois, 62526
Study site
Hot Springs, Arkansas, 71913
Study site
Houston, Texas, 77030
Study site
Livingston, New Jersey, 07039
Study site
Minneapolis, Minnesota, 55455
Study site
New Albany, Indiana, 47150
Study site
New York, New York, 10021
Study site
Palm Springs, California, 92262
Study site
Pittsburgh, Pennsylvania, 15213-3180
Study site
Portland, Oregon, 97239
Study site
San Antonio, Texas, 78207
Study site
Syracuse, New York, 13210
Study site
Tacoma, Washington, 98405
Study site
Tucson, Arizona, 85724
Study site
Washington D.C., District of Columbia, 20007
Canada4 sites
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Montreal, Quebec, H3T 1E2
Study site
Québec, Quebec, G1S 4L8
Study site
Toronto, Ontario, M4N 3M5
About this study
Official title: Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
Read the detailed description
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
- Conditions
- Breast Neoplasm
- Being tested
- Sagopilone (ZK 219477)
- Keywords
- Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone (ZK 219477)Drug
Also called BAY86-5302
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Sagopilone (ZK 219477)Drug
Also called BAY86-5302
Patients will receive 22mg/m2 as intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Sagopilone (ZK 219477) |
| Arm 2 | Experimental | Not described Receives: Drug: Sagopilone (ZK 219477) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment with ZK-Epo after 6 cycles
Measured: complete or partial response after 2 to 6 courses of therapy.
Secondary outcomes (1)
Safety and tolerability of ZK-Epo
Measured: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2008
- Study completionNov 2008
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 Breast 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
- 65 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
- NCT00313248
- Sponsor's protocol ID
- 91466
- Other IDs
- 307975
- Status last verified
- Nov 2015
- First submitted
- 11 Apr 2006
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10.
PubMed 20697802
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00313248
- Acronym / sponsor ID
- 91466
- Conditions
- Breast Neoplasm
- Keywords
- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Apr 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 evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
Detailed description
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sagopilone (ZK 219477) |
| Arm 2 | Experimental | Drug: Sagopilone (ZK 219477) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metastatic breast cancer (meaning the cancer has spread beyond its original location)
- At least one measurable lesion by CT or MRI
- Progression of disease following previous therapy for breast cancer
- Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
- Not be pregnant
Key exclusion criteria (5 listed)
- More than 3 previous chemotherapy regimens
- More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
- Prior treatment with epothilones (e.g. Ixabepilone)
- Symptomatic brain metastases
- Additional criteria to be determined at screening visit
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 (ZK 219477)Also: BAY86-5302All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer. | Drug | Arm 1 |
| Sagopilone (ZK 219477)Also: BAY86-5302Patients will receive 22mg/m2 as intravenous infusion. | Drug | Arm 2 |
Primary outcome
Response to treatment with ZK-Epo after 6 cycles
Time frame: complete or partial response after 2 to 6 courses of therapy.
1 secondary outcome
Safety and tolerability of ZK-Epo
Time frame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
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 10 Dec 2015.
- Derived from this study: PubMed 20697802Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10.
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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
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sagopilone (ZK 219477) in people with Breast Neoplasm, run by Bayer at 25 sites in 2 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 6 inclusion and 5 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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?
Response to treatment with ZK-Epo after 6 cycles (time frame: complete or partial response after 2 to 6 courses of therapy.). 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 NCT00313248, 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 10 Dec 2015.