ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
|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
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|