PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
NCT ID: NCT03284723
Last Updated: 2024-09-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
95 participants
INTERVENTIONAL
2017-11-01
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-06804103
Study Treatment
PF-06804103
Dose Escalation Part - 1A Dose Expansion Part - 2A
PF-06804103+Combination Regimen
Study Treatment
PF-06804103 + Palbociclib +Letrozole
Dose Escalation - Part 1B Dose Expansion - Part 2B
Interventions
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PF-06804103
Dose Escalation Part - 1A Dose Expansion Part - 2A
PF-06804103 + Palbociclib +Letrozole
Dose Escalation - Part 1B Dose Expansion - Part 2B
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Banner-University Medical Center Tucson
Tucson, Arizona, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
UCLA Health (main campus)
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Santa Monica - UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California, United States
UCLA Dept of Medicine - Hematology/Oncology, Santa Monica
Santa Monica, California, United States
UCLA Health, Santa Monica
Santa Monica, California, United States
Northside Hospital Inc.- GCS/Athens
Athens, Georgia, United States
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, United States
Northside Hospital, Inc. - GCS/Northside
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northside Hospital,Inc.-GCS /Blairsville
Blairsville, Georgia, United States
Northside Hospital, Inc. - GCS/Canton
Canton, Georgia, United States
Atlanta Cancer Care - Cumming
Cumming, Georgia, United States
Northside Hospital, Inc.-GCS/Stemmer
Decatur, Georgia, United States
Suburban Hematology-Oncology Associates - Duluth
Duluth, Georgia, United States
Atlanta Cancer Care - Lake Spivey
Jonesboro, Georgia, United States
Suburban Hematology-Oncology Associates- Lawrenceville
Lawrenceville, Georgia, United States
Northside Hospital, Inc. - GCS/Macon
Macon, Georgia, United States
Northside Hospital, Inc. GCS/Kennestone
Marietta, Georgia, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Macquarie University
Macquarie Park, New South Wales, Australia
Istituto Clinico Humanitas U. O. Oculistica
Milan, Lombardy, Italy
Azienda Socio-Sanitaria Territoriale Monza
Monza, MB, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, Italy
Divisione di Cardiologia - Istituto Europeo di Oncologia Divisione di Medicina Nucleare
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
LLC "Clinica UZI 4D"
Pyatigorsk, Stavropol Kray, Russia
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Saint Petersburg, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Countries
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References
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Meric-Bernstam F, Calvo E, Lee KS, Moreno V, Park YH, Rha SY, Chalasani P, Zhong W, Zhou L, Pirie-Shepherd S, Leung ACF, Curigliano G. Safety and Tolerability of a Novel Anti-HER2 Antibody-Drug Conjugate (PF-06804103) in Patients with HER2-Expressing Solid Tumors: A Phase 1 Dose-Escalation Study. Mol Cancer Ther. 2023 Oct 2;22(10):1191-1203. doi: 10.1158/1535-7163.MCT-23-0101.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2017-002538-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C0541001
Identifier Type: -
Identifier Source: org_study_id
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