Breast Cancer Clinical Trial
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
Summary
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.
Eligibility Criteria
Inclusion Criteria:
HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
HER2 positive and negative breast cancer (Part 2A)
HER2 negative breast cancer (Part 1B & Part 2B)
Performance status of 0 or 1
Adequate bone marrow, kidney and liver function
Exclusion Criteria:
Known CNS disease including, but not limited to, metastases
History of exposure to certain cumulative doses of anthracyclines
Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
Active and clinically significant bacterial, fungal, or viral infection
Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases
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There are 38 Locations for this study
Tucson Arizona, 85719, United States
Tucson Arizona, 85719, United States
Tucson Arizona, 85724, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Santa Monica California, 90404, United States
Santa Monica California, 90404, United States
Santa Monica California, 90404, United States
Athens Georgia, 30606, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Blairsville Georgia, 30512, United States
Canton Georgia, 30114, United States
Cumming Georgia, 30041, United States
Decatur Georgia, 30033, United States
Duluth Georgia, 30096, United States
Jonesboro Georgia, 30236, United States
Lawrenceville Georgia, 30046, United States
Macon Georgia, 31217, United States
Marietta Georgia, 30060, United States
Omaha Nebraska, 68130, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84112, United States
Camperdown New South Wales, 2050, Australia
Macquarie University New South Wales, 2109, Australia
Monza MB, 20900, Italy
Razzano Milan, 20089, Italy
Milano MI, 20133, Italy
Milano MI, 20141, Italy
Milano MI, 20141, Italy
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Pyatigorsk Stavropol Region, 35750, Russian Federation
Saint-Petersburg , 19527, Russian Federation
Pozuelo de Alarcón Madrid, 28223, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
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