ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00496379|
Recruitment Status : Terminated (This study has closed to accrual early due to slow accrual.)
First Posted : July 4, 2007
Results First Posted : March 12, 2013
Last Update Posted : March 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer CNS Disease||Drug: ZK219477||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||January 2012|
Given intravenously over approximately 30 minutes once every 3 weeks
- 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.
- Number of Subjects With Adverse Events (Any Grade) [ Time Frame: 2 years ]Adverse events per NCI CTCAE
- Objective Response Rate in Non-Central Nervous System (CNS) Sites [ Time Frame: 2 years ]Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
- Time to Progression at Any Site. [ Time Frame: 2 years ]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
- Clinical Benefit Rate. [ Time Frame: 2 years ]CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496379
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nancy Lin, MD||Dana-Farber Cancer Institute|