- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00496379
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
March 12, 2013 updated by: Nancy Lin, MD
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ZK219477
|
Given intravenously over approximately 30 minutes once every 3 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Adverse Events (Any Grade)
Time Frame: 2 years
|
Adverse events per NCI CTCAE
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2 years
|
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Time Frame: 2 years
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Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
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2 years
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Time to Progression at Any Site.
Time Frame: 2 years
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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
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2 years
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Clinical Benefit Rate.
Time Frame: 2 years
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CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
July 3, 2007
First Submitted That Met QC Criteria
July 3, 2007
First Posted (Estimate)
July 4, 2007
Study Record Updates
Last Update Posted (Estimate)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 12, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neoplastic Processes
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Breast Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
- Central Nervous System Diseases
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Epothilones
- Sagopilone
Other Study ID Numbers
- 06-268
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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