CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 112 enrolled
Drug / intervention
Ixazomib 2.5 mg +6 moredrug
Likely dose
Ixazomib 2.5 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.

Search/NCT01454076
NCT01454076Phase 1Completed
CompareCT.gov

A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

Millennium Pharmaceuticals, Inc.·interventional·Posted Oct 18, 2011·Updated Nov 1, 2017

In Brief

A Phase 1 clinical trial evaluating Ixazomib 2.5 mg, Ixazomib 4 mg Capsule A, and 4 other interventions for Nonhematologic Malignancies and Lymphoma. Completed, enrolled 112 participants across 1 site.

Detailed Summary

This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonhematologic Malignancies, Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2011
Enrollment StartNov 10, 2011
Primary CompletionApr 1, 2015
Study CompletionJun 16, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.7 years ago

Interventions

Ixazomib 2.5 mgdrug

Ixazomib 2.5 mg Capsule B (Cycle 1 only)

Ixazomib 4 mg Capsule Adrug

Ixazomib 4 mg Capsule A (Cycle 1 only)

Ixazomib 4 mg Capsule Bdrug

Ixazomib 4 mg Capsule B (Cycle 2 and beyond )

Ketoconazoledrug

Ketoconazole 400 mg tablets (Cycle 1 only)

Rifampindrug

Rifampin 600 mg capsule (Cycle 1 only)

Clarithromycindrug

Clarithromycin 500 mg tablets (Cycle 1 only)

Ixazomib 4 mg Capsule Bdrug

Ixazomib 4 mg Capsule B (Cycle 1 and beyond)