CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
IXAZOMIBdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Advanced malignancy (solid tumor or hematologic) without effective standard/curative/life-prolonging treatment options
  • ✓ECOG performance status 0 to 1
  • ✓Hepatic function stratified from normal to severe impairment (total bilirubin ≤ULN or >1.5-3x ULN or >3x ULN)
Key exclusion· 10
  • ✕CYP3A or CYP1A2 inhibitor/inducer use, Ginkgo biloba, or St. John's wort within 14 days
  • ✕Nicotine-containing products within 14 days
  • ✕CNS involvement or symptomatic brain metastases (treated/stable brain metastases allowed with 2-week neurologic stability post-therapy)
  • ✕Investigational products or radiotherapy within 21 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01912222
NCT01912222Phase 1Completed
CompareCT.gov

A Phase 1 Pharmacokinetic Study of Oral IXAZOMIB (MLN9708) in Patients With Advanced Solid Tumors or Hematologic Malignancies With Varying Degrees of Liver Dysfunction

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 31, 2013·Updated Jun 2, 2016

In Brief

A Phase 1 clinical trial evaluating IXAZOMIB for Advanced Solid Tumors and Hematologic Malignancies. Completed, enrolled 48 participants across 4 sites.

Detailed Summary

This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Hematologic Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 31, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.9 years ago

Interventions

IXAZOMIBdrug