A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
NCT ID: NCT02129205
Last Updated: 2019-03-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
40 participants
INTERVENTIONAL
2014-06-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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PF-06650808
PF-06650808
Dose Escalation Phase \[Part 1\] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
PF-06650808
Dose Expansion Phase \[Part 2\] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Interventions
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PF-06650808
Dose Escalation Phase \[Part 1\] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
PF-06650808
Dose Expansion Phase \[Part 2\] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Eligibility Criteria
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Inclusion Criteria
* Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion
* Adequate bone marrow, renal and liver function
Exclusion Criteria
* Patients with known symptomatic brain metastases requiring steroids
* Prior treatment with a compound of the same mechanism
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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Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Westwood Bowyer Clinic
Los Angeles, California, United States
Santa Monica - UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
The OSU Investigational Drug Services
Columbus, Ohio, United States
The OSU Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Countries
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References
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Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18.
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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B7501001
Identifier Type: -
Identifier Source: org_study_id
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