Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2019-04-05
2019-10-24
Brief Summary
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Detailed Description
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Approximately 18 participants will be enrolled into the study to ensure at least 6 PK evaluable (having data for estimating primary PK parameters for dacomitinib) participants in each cohort.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cohort 1 (Dacomitinib)
severe hepatic impairment group
Dacomitinib
anti-cancer agent
Cohort 2 (Dacomitinib)
normal hepatic function
Dacomitinib
anti-cancer agent
Interventions
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Dacomitinib
anti-cancer agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male and/or female participants of non childbearing potential must be 18 to 75 years of age, inclusive, at the time of signing the informed consent document (ICD).
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Weight:
3. Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb).
4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria
1. Any condition possibly affecting drug absorption (eg, gastrectomy).
2. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
3. History of or current positive results for human immunodeficiency virus (HIV).
4. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP used in this study (whichever is longer).
5. Hypersensitivity to dacomitinib or its excipients.
6. A positive urine drug test. Participants with severe hepatic impairment (Cohort 1) will be eligible to participate if their urine drug test is positive with a drug for a prescribed condition that is not expected to interfere with the PK of dacomitinib.
7. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
8. History of sensitivity to heparin or heparin induced thrombocytopenia.
9. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
10. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.
18 Years
75 Years
ALL
Yes
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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Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
Miami, Florida, United States
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Countries
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References
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Piscitelli J, Chen J, LaBadie RR, Salageanu J, Chung CH, Tan W. The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib. Clin Drug Investig. 2022 Mar;42(3):221-235. doi: 10.1007/s40261-022-01125-x. Epub 2022 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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A7471058
Identifier Type: -
Identifier Source: org_study_id