This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Pfizer Investigational Site
Manhasset, New York, United States
Pfizer Investigational Site
New York, New York, United States
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
Time to tumor response (TAR)
Duration of response (DR)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Overall survival (OS)
Clinical benefit
ie, a composite profile of pain intensity
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Plasma pharmacokinetic parameters
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Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Orange, Ohio, United States
Pfizer Investigational Site
Westlake, Ohio, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
East Bentleigh, Victoria, Australia
Pfizer Investigational Site
Parkville, Victoria, Australia
Pfizer Investigational Site
Brussels, Belgium
...and 9 more locations