Clinical Trials Directory

Trials / Completed

CompletedNCT01482962

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
271 (actual)
Sponsor
Millennium Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

Detailed description

The drug being tested in this study was Alisertib. Alisertib was tested to treat people who have relapsed/refractory peripheral T-cell lymphoma (PTCL). This study evaluated alisertib for the improvement in overall response rate (ORR) compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate, romidepsin (US only), or gemcitabine, in participants with relapsed or refractory PTCL. The study enrolled 271 patients. Participants were randomized (1:1) to one of 2 treatment arms: * Alisertib * Investigator's choice (Pralatrexate, Romidepsin, or Gemcitabine) This multi-center trial was conducted worldwide. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and then were contacted by telephone up to 42-months after the last participant was randomized, or until death, for follow-up assessment.

Conditions

Interventions

TypeNameDescription
DRUGAlisertibAlisertib enteric coated tablets
DRUGPralatrexatePralatrexate IV infusion
DRUGGemcitabineGemcitabine IV infusion
DRUGRomidepsinRomidepsin IV infusion

Timeline

Start date
2012-06-11
Primary completion
2015-06-30
Completion
2017-12-18
First posted
2011-12-01
Last updated
2018-07-31
Results posted
2018-07-31

Locations

151 sites across 31 countries: United States, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Egypt, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT01482962. Inclusion in this directory is not an endorsement.