At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 88 enrolled
Drug / intervention
crizotinib +4 moredrug
Likely dose
crizotinib 250 mgfrom 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 I Study To Evaluate The Effect Of Hepatic Impairment On The Pharmacokinetics And Safety Of Crizotinib In Advanced Cancer Patients
In Brief
A Phase 1 clinical trial evaluating crizotinib for Advanced Cancer. Completed, enrolled 88 participants across 20 sites.
Detailed Summary
This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer patients with mild, moderate or severe liver dysfunction as well as patients with normal liver function will be enrolled in this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartJul 2012
Primary CompletionJun 2016
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.2 years ago
Interventions
crizotinibdrug
crizotinib 250 mg twice a day
crizotinibdrug
crizotinib 250 mg once a day
crizotinibdrug
crizotinib 250 mg twice a day
crizotinibdrug
crizotinib 250 mg once a day
crizotinibdrug
crizotinib 250 mg once a day