NCT00651664

A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Participants With Advanced Malignancies

A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, dose escalation, phase 1 study of MLN8237 in adult participants with advanced malignancies (excluding those with primary bone marrow involvement, such as leukemias and multiple myeloma).

Detailed description

The drug tested in this study is called alisertib. Alisertib is being tested to treat people who have advanced malignancies. This study determined the dose-limiting toxicity, maximum tolerated dose, safety and pharmacokinetics (how the drug moves through the body) for alisertib when given once or twice a day for 7 to 21 days. This open label study enrolled 59 patients. Participants were enrolled in one of 10 dose escalation arms: * Alisertib 5 mg once daily (QD) for 7 Days (D) * Alisertib 80 mg QD 7D * Alisertib 150 mg QD 7D * Alisertib 50 mg twice daily (BID) 7D * Alisertib 60 mg BID 7D * Alisertib 75 mg BID 7D * Alisertib 100 mg BID 7D * Alisertib 50 mg QD 14D * Alisertib 50 mg QD 21D * Alisertib 70 mg QD 21D All participants received treatment until their disease progressed or they experienced unacceptable alisertib-related toxicity. This multi-center trial was conducted in Spain. The overall time to participate in this study was 730 days. Participants made multiple visits to the clinic, including a final visit 30 days after receiving their last dose of alisertib for a follow-up assessment.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	alisertib	Alisertib (MLN8237) capsules

Timeline

• Start date: 2007-10-22
• Primary completion: 2010-09-01
• Completion: 2011-04-05
• First posted: 2008-04-03
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

2 sites across 1 country: Spain