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Trial record 1 of 1 for:    NCT03865446
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Evaluate Severe Hepatic Impairment on Dacomitinib PK

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ClinicalTrials.gov Identifier: NCT03865446
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE April 5, 2019
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of dacomitinib [ Time Frame: Day 1 to Day 12 ]
    PK parameter of dacomitinib to be calculated from the plasm concentration time data
  • Maximum observed plasma concentration (Cmax) of dacomitinib [ Time Frame: Day 1 ]
    PK parameter of dacomitinib to be calculated from the plasma concentration time data
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03865446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Number of participants experienced treatment emergent adverse event assessed by investigator [ Time Frame: Baseline up to Day 35 ]
    Type, incidence, severity, seriousness, and relationship to study medications of adverse events (AE)
  • Number of participants experienced treatment related adverse event assessed by investigator [ Time Frame: Baseline up to Day 35 ]
    Type, incidence, severity, seriousness, and relationship to study medications of adverse events (AE)
  • Number of participants experienced serious adverse event assessed by investigator [ Time Frame: Baseline up to Day 35 ]
    Type, incidence, severity, seriousness, and relationship to study medications of adverse events (AE)
  • Number of participants with abnormal laboratory test values assessed by investigator (Hematology) [ Time Frame: Baseline up to Day 12 ]
    The total number of participants with hematology laboratory test abnormalities will be assessed by investigator.
  • Number of participants with abnormal laboratory test values assessed by investigator (Blood chemistry) [ Time Frame: Baseline up to Day 12 ]
    The total number of participants with blood chemistry test abnormalities will be assessed by investigator
  • Number of participants with change from baseline and absolute values in vital signs (blood pressure) meeting criteria of potential clinical concern [ Time Frame: Baseline up to Day 12 ]
    Blood pressure (BP) will be summarized using actual values and changes from baseline. The participants meeting criteria of potential clinical concern will be judged by investigator.
  • Number of participants with change from baseline and absolute values in QTcF meeting criteria of potential clinical concern [ Time Frame: Baseline up to Day 12 ]
    Federicia corrected QT (QTcF) will be summarized using actual values and changes from baseline. The participants meeting criteria of potential clinical concern will be judged by investigator.
  • Number of participants with change from baseline and absolute values in heart rate meeting criteria of potential clincial concern [ Time Frame: Baseline up to Day 12 ]
    Heart rate will be summarized using actual values and change from baseline. The participants meeting criteria of potential clinical concern will be judged by investigator
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Severe Hepatic Impairment on Dacomitinib PK
Official Title  ICMJE A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF DACOMITINIB IN PARTICIPANTS WITH SEVERELY IMPAIRED HEPATIC FUNCTION RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Brief Summary This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
Detailed Description

This is a Phase 1, open label, parallel group study to investigate the effect of severe hepatic impairment on the plasma PK, safety and tolerability after a single oral 30 mg dose of dacomitinib under fasted conditions.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Severe Hepatic Impairment
Intervention  ICMJE Drug: Dacomitinib
anti-cancer agent
Other Name: PF-00299804; VIZIMPRO
Study Arms  ICMJE
  • Experimental: Cohort 1 (Dacomitinib)
    severe hepatic impairment group
    Intervention: Drug: Dacomitinib
  • Experimental: Cohort 2 (Dacomitinib)
    normal hepatic function
    Intervention: Drug: Dacomitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
18
Actual Study Completion Date  ICMJE October 24, 2019
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  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:

Participants are excluded from the study if any of the following criteria apply:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03865446
Other Study ID Numbers  ICMJE A7471058
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP