ZK219477 (Sagopilone) 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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases|
- Objective Response Rate in the Central Nervous System (CNS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Adverse events per NCI CTCAE
- Objective Response Rate in Non-Central Nervous System (CNS) Sites [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
|Study Start Date:||July 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Given intravenously over approximately 30 minutes once every 3 weeks
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496379
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nancy Lin, MD||Dana-Farber Cancer Institute|