At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Dacomitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Dacomitinib for Severe Hepatic Impairment. Completed, enrolled 16 participants across 3 sites.
Detailed Summary
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartApr 2019
Primary CompletionOct 2019
TodayJul 2026
First PostedMar 6, 2019
Enrollment StartApr 5, 2019
Primary CompletionOct 24, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.3 years ago
Interventions
Dacomitinibdrug
anti-cancer agent