NCT00807495

Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.

Detailed description

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have relapsed or refractory non-Hodgkin's lymphoma (NHL). The study looked at anti-tumor activity in participants who received alisertib. The study enrolled 48 patients. Participants were categorized as per disease subtypes into five subtypes: Large B-Cell lymphoma, mantle cell lymphoma, transformed follicular lymphoma, Burkitts lymphoma and aggressive T-Cell lymphoma (Note: There were no participants enrolled with Precursor B-lymphoblastic Leukemia/Lymphoma). Participants received: • Alisertib 50 mg BID on Days 1 to 7 All participants took alisertib capsules approximately every 12 hours each day for 7 days followed by a 14-day rest period in a 21-days cycle. MLN8237 was supplied in capsules of 5 or 25 mg strength. This multi-center trial was conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. If the participant would derive benefit from continued alisertib treatment beyond 24 months, the Sponsor was consulted for approval of further treatment. Participants made multiple visits to the clinic, with imaging assessments every 12 weeks. Participants discontinuing treatment prior to disease progression continue with clinic visits, chemistry and hematology lab testing, and tumor assessments every 12 weeks up to 12 months after last dose of study drug for follow-up assessments.

Conditions

• Diffuse Large B-cell Lymphoma
• Mantle Cell Lymphoma
• Burkitt's Lymphoma
• T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma
• Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib capsules

Timeline

• Start date: 2009-02-10
• Primary completion: 2011-01-04
• Completion: 2013-02-13
• First posted: 2008-12-12
• Last updated: 2018-03-27
• Results posted: 2018-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study