At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 51 enrolled
Drug / intervention
MLN4924 +5 moredrug
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 Study to Evaluate the Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating MLN4924, Fluconazole, and 4 other interventions for Advanced Solid Tumors. Completed, enrolled 51 participants across 4 sites.
Detailed Summary
The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionJun 2017
TodayJul 2026
First PostedApr 25, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 5, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.2 years ago
Interventions
MLN4924drug
MLN4924 intravenous solution.
Fluconazoledrug
Fluconazole tablets.
Itraconazoledrug
Itraconazole oral solution.
Docetaxeldrug
Docetaxel intravenous solution.
Carboplatindrug
Carboplatin intravenous solution.
Paclitaxeldrug
Paclitaxel intravenous solution.