Clinical Trials Directory

Trials / Completed

CompletedNCT01397825

MLN8237 in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab +/- Vincristine

A Multicenter, Phase 1-2 Study of MLN8237, an Oral Aurora A Kinase Inhibitor, in Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Rituximab and Vincristine

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Millennium Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a single-arm, open-label, multicenter, dose escalation, phase 1-2 study of alisertib (MLN8237) administered in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)/transformed follicular lymphoma (TFL) treated with rituximab and vincristine. The study has three parts as follows: Phase 1, Part 1: Safety lead-in cohort to evaluate alisertib (MLN8237) and rituximab. Phase 1, Part 2: Dose escalation cohort to evaluate alisertib (MLN8237) + Rituximab + Vincristine and determine Phase 2 dose. Patients with other types of B-cell lymphoma (including mantle cell or Burkitt's lymphoma may enroll in Parts 1 and 2. Phase 2: Alisertib (MLN8237) + Rituximab + Vincristine in patients with relapsed or refractory DLBCL or TFL at recommended Phase 2 dose. Note that in 2013 Sponsor decision was taken to not initiate the phase 2 portion of the trial, which would have investigated the triplet at the recommended phase 2 dose identified in part 2. This decision was based on reprioritization within the company and not on any clinical or safety outcomes observed.

Detailed description

The drug tested in this study was called alisertib. Alisertib was tested to treat people who have relapsed or refractory diffuse large B-cell lymphoma or other aggressive B-cell lymphomas. This study looked at safety, any anti-tumor effect, and it also determined a recommended dose of alisertib plus rituximab and alisertib plus rituximab and vincristine to take into further studies. Pharmacokinetic blood samples were studied to characterize any effects on the concentration of each of the drugs when administered together . The study enrolled 45 patients. Participants received the following treatments: Phase 1 * Alisertib 50 mg + rituximab in the Safety Lead-in * Alisertib 30 mg + rituximab + vincristine in the Dose Escalation * Alisertib 40 mg + rituximab + vincristine in the Dose Escalation * Alisertib 50 mg + rituximab + vincristine in the Dose Escalation All participants were asked to take one alisertib table twice a day for 7 days in each cycle for up to 8 cycles along with rituximab on Day 1 of each cycle; some patients also received vincristine on Day 1 and Day 8 of each cycle. All participants with documented disease response or stabilization could continue with alisertib single-agent therapy for an additional 2 years or more. This multi-center trial was conducted in the USA. The overall time to participate in this study was up to 5.2 years. Participants made multiple visits to the clinic, plus a final visit 30 days after receiving their last dose of study drug for a follow-up assessment.

Conditions

Interventions

TypeNameDescription
DRUGAlisertib (MLN8237)Alisertib (MLN8237) enteric coated tablet (ECT).
DRUGRituximabRituximab IV infusion.
DRUGVincristineVincristine IV Infusion.

Timeline

Start date
2011-08-09
Primary completion
2015-02-05
Completion
2016-10-05
First posted
2011-07-20
Last updated
2018-03-27
Results posted
2018-03-27

Locations

25 sites across 4 countries: United States, Italy, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT01397825. Inclusion in this directory is not an endorsement.