CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 116 enrolled
Drug / intervention
IXAZOMIBdrug
Likely dose
IXAZOMIB 0.125 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/NCT00830869
NCT00830869Phase 1Completed
CompareCT.gov

An Open-Label, Dose Escalation, Phase 1 Study of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies

Millennium Pharmaceuticals, Inc.·interventional·Posted Jan 28, 2009·Updated Sep 9, 2019

In Brief

A Phase 1 clinical trial evaluating IXAZOMIB for Advanced Non-hematologic Malignancies. Completed, enrolled 116 participants across 7 sites in 2 countries.

Detailed Summary

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Non-hematologic Malignancies
CountriesCanada, United States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2009
Enrollment StartMar 2, 2009
Primary CompletionApr 20, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.4 years ago

Interventions

IXAZOMIBdrug

All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days. The first stage of the study will be initiated at a starting dose of 0.125 mg/m\^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.