Breast CancerPhase 2NCT00496379
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
A Phase 2 study testing ZK219477 in people with Breast Cancer and CNS Disease, run by Nancy Lin, MD at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, CNS Disease
- What is being tested?
- ZK219477
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
- Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
- New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
- Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
- No increase in corticosteroid use in the week prior to study entry
- Any number prior lines of chemotherapy for metastatic breast cancer
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- 18 years of age of older
- Life expectancy of greater than 12 weeks
- ECOG Performance Status 0-2
- Patients must have normal organ function as outlined in the protocol
Who cannot join
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
- Patients may not be receiving any other investigational agent
- Patients may not be receiving any cancer-directed therapy
- Prior treatment with investigational chemotherapy for brain metastases
- Prior treatment with epothilone for metastatic breast cancer
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- Leptomeningeal carcinomatosis as the only site of CNS involvement.
- Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
- More than 2 seizures over the last four weeks prior to study entry
- Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
Read the detailed description
- Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
- During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
- At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
- After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
- At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.
- Conditions
- Breast Cancer, CNS Disease
- Being tested
- ZK219477
- Keywords
- metastatic breast cancer, invasive breast cancer, brain metastases, ZK-EPO
- Medical subject headings
- Breast Neoplasms, Central Nervous System Diseases, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZK219477Drug
Also called ZK-EPO, ZK-Epothilone, Sagopilone
Given intravenously over approximately 30 minutes once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ZK219477 | Experimental | Not described Receives: Drug: ZK219477 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate in the Central Nervous System (CNS)
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
Measured: 2 years
Secondary outcomes (4)
Number of Subjects With Adverse Events (Any Grade)
Adverse events per NCI CTCAE
Measured: 2 years
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
Measured: 2 years
Time to Progression at Any Site.
Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0
Measured: 2 years
Clinical Benefit Rate.
CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2009
- Study completionJan 2012
Why it stopped: This study has closed to accrual early due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Lin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Bayer, Breast Cancer Research Foundation
- Responsible party
- Sponsor-investigator, Nancy Lin, MD, Dana-Farber Cancer Institute
- Investigators
- Nancy Lin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496379
- Sponsor's protocol ID
- 06-268
- Status last verified
- Mar 2013
- First submitted
- 3 Jul 2007
- Last updated
- 14 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
- ClinicalTrials.gov ID
- NCT00496379
- Acronym / sponsor ID
- 06-268
- Conditions
- Breast Cancer, CNS Disease
- Keywords
- metastatic breast cancer, invasive breast cancer, brain metastases, ZK-EPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has closed to accrual early due to slow accrual.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nancy Lin, MDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Bayer, Breast Cancer Research Foundation
- Study start
- Jul 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 12 Mar 2013
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 research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
Detailed description
- Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
- During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
- At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
- After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
- At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZK219477 | Experimental | Drug: ZK219477 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
- Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
- New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
- Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
- No increase in corticosteroid use in the week prior to study entry
Key exclusion criteria (12 listed)
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
- Patients may not be receiving any other investigational agent
- Patients may not be receiving any cancer-directed therapy
- Prior treatment with investigational chemotherapy for brain metastases
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 |
|---|---|---|
| ZK219477Also: ZK-EPO, ZK-Epothilone, SagopiloneGiven intravenously over approximately 30 minutes once every 3 weeks | Drug | ZK219477 |
Primary outcome
Objective Response Rate in the Central Nervous System (CNS)
Time frame: 2 years
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
4 secondary outcomes
Number of Subjects With Adverse Events (Any Grade)
Time frame: 2 years
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Time frame: 2 years
Time to Progression at Any Site.
Time frame: 2 years
Clinical Benefit Rate.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Lin, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZK219477 in people with Breast Cancer and CNS Disease, run by Nancy Lin, MD at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate in the Central Nervous System (CNS) (time frame: 2 years). 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 14 Mar 2013.