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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT03284723

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 38 Locations for this study

See Locations Near You

Banner-University Medical Center Tucson
Tucson Arizona, 85719, United States
The University of Arizona Cancer Center - North Campus
Tucson Arizona, 85719, United States
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
UCLA Health (main campus)
Los Angeles California, 90095, United States
UCLA Hematology/Oncology
Los Angeles California, 90095, United States
Santa Monica - UCLA Medical Center and Orthopaedic Hospital
Santa Monica California, 90404, United States
UCLA Dept of Medicine - Hematology/Oncology, Santa Monica
Santa Monica California, 90404, United States
UCLA Health, Santa Monica
Santa Monica California, 90404, United States
Northside Hospital Inc.- GCS/Athens
Athens Georgia, 30606, United States
Atlanta Cancer Care - Atlanta
Atlanta Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Northside
Atlanta Georgia, 30342, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Northside Hospital,Inc.-GCS /Blairsville
Blairsville Georgia, 30512, United States
Northside Hospital, Inc. - GCS/Canton
Canton Georgia, 30114, United States
Atlanta Cancer Care - Cumming
Cumming Georgia, 30041, United States
Northside Hospital, Inc.-GCS/Stemmer
Decatur Georgia, 30033, United States
Suburban Hematology-Oncology Associates - Duluth
Duluth Georgia, 30096, United States
Atlanta Cancer Care - Lake Spivey
Jonesboro Georgia, 30236, United States
Suburban Hematology-Oncology Associates- Lawrenceville
Lawrenceville Georgia, 30046, United States
Northside Hospital, Inc. - GCS/Macon
Macon Georgia, 31217, United States
Northside Hospital, Inc. GCS/Kennestone
Marietta Georgia, 30060, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Macquarie University
Macquarie University New South Wales, 2109, Australia
Azienda Socio-Sanitaria Territoriale Monza
Monza MB, 20900, Italy
Istituto Clinico Humanitas U. O. Oculistica
Razzano Milan, 20089, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milano MI, 20133, Italy
Divisione di Cardiologia - Istituto Europeo di Oncologia Divisione di Medicina Nucleare
Milano MI, 20141, Italy
Istituto Europeo di Oncologia
Milano MI, 20141, Italy
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
LLC "Clinica UZI 4D"
Pyatigorsk Stavropol Region, 35750, Russian Federation
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Saint-Petersburg , 19527, Russian Federation
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón Madrid, 28223, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT03284723

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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