Evaluate Severe Hepatic Impairment on Dacomitinib PK

NCT03865446 | Completed Phase 1 Results FDA Drug

• 1 other identifier: A7471058
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.

Conditions

Severe Hepatic Impairment

Keywords

Pharmacokinetics; Dacomitinib; Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Dacomitinib

  Cmax of Dacomitinib was analyzed.

  Pre-dose and 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 264 hours post dose on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Dacomitinib

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

  Pre-dose and 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 264 hours post dose on Day 1

Secondary Outcomes (5)

• Number of Participants With Laboratory Abnormalities

  Baseline up to Day 7

• Number of Participants With Physical Examination Abnormalities

  Baseline up to Day 7

• Number of Participants With Vital Sign Parameters Meeting Criteria of Potential Clinical Concern

  Baseline up to Day 7

• Number of Participants With ECG Parameters Meeting Criteria of Potential Clinical Concern

  Baseline up to Day 7

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Day 35

Other Outcomes (1)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Baseline up to Day 35

Study Arms (2)

Cohort 1 (Dacomitinib)

EXPERIMENTAL

severe hepatic impairment group

Drug: Dacomitinib

Cohort 2 (Dacomitinib)

EXPERIMENTAL

normal hepatic function

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

anti-cancer agent

Also known as: PF-00299804; VIZIMPRO

Cohort 1 (Dacomitinib); Cohort 2 (Dacomitinib)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• 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).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Weight:
• Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb).
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• 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.
• History of or current positive results for human immunodeficiency virus (HIV).
• 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).
• Hypersensitivity to dacomitinib or its excipients.
• 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.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin induced thrombocytopenia.
• Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy

Miami, Florida, 33136, United States

Location

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Publications (1)

• 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.

  PMID: 35195881 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

dacomitinib

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 6, 2019
• Study Start: April 5, 2019
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: November 6, 2020
• Results First Posted: November 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)