A Study Of PF-06647263 In Patients With Advanced Solid Tumors
NCT ID: NCT02078752
Last Updated: 2019-04-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
60 participants
INTERVENTIONAL
2014-04-09
2017-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1
PF-06647263
Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
PF-06647263
Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Interventions
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PF-06647263
Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
PF-06647263
Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Eligibility Criteria
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Inclusion Criteria
* Performance Status of 0 or 1
* Adequate bone marrow, kidney, and liver function
* Part 2 includes advanced triple negative breast cancer patients.
Exclusion Criteria
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
* Active and clinically significant bacterial, fungal or viral infection
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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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital (BWH)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Hospital / University of Utah
Salt Lake City, Utah, United States
Huntsman Cancer Institute-University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Garrido-Laguna I, Krop I, Burris HA 3rd, Hamilton E, Braiteh F, Weise AM, Abu-Khalaf M, Werner TL, Pirie-Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors. Int J Cancer. 2019 Oct 1;145(7):1798-1808. doi: 10.1002/ijc.32154. Epub 2019 Feb 23.
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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B7521001
Identifier Type: -
Identifier Source: org_study_id
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