At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 46 enrolled
Drug / intervention
Carfilzomibdrug
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.
An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Advanced Malignancies and Varying Degrees of Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Carfilzomib for Solid Tumors and 2 related conditions. Completed, enrolled 46 participants across 11 sites in 4 countries.
Detailed Summary
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors, Hematologic Malignancies, Hepatic Impairment
CountriesFrance, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionAug 2015
Study CompletionSep 2015
TodayJul 2026
First PostedSep 24, 2013
Enrollment StartOct 1, 2013
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago
Interventions
Carfilzomibdrug
Carfilzomib was administered by IV injection over 30 minutes