NCT02259010

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

A Phase 1 Study to Evaluate the Effect of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.

Detailed description

The drug being tested in this study is called alisertib. Alisertib is being tested in adult participants with advanced solid tumors or relapsed refactory lymphoma. The study will look at the effect of the pharmacokinetics (how the drug moves through the body) of alisertib in the presence and absence of itraconazole. This is an open label study. Participants will receive: * Alisertib tablets 30 mg in Part A and 50 mg in Part B * Itraconazole oral solution 200 mg in Part A Participation in Part A is approximately 25 days. Part B participation is repeating 21-day cycles. The maximum duration of treatment with alisertib will be 12 months (approximately 16 cycles) unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. This multi-center study will take place in the United States.

Conditions

• Advanced Solid Tumors
• Relapsed/Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib tablets
DRUG	Itraconazole	Itraconazole oral solution

Timeline

• Start date: 2014-10-22
• Primary completion: 2015-03-27
• Completion: 2016-10-21
• First posted: 2014-10-08
• Last updated: 2019-09-20
• Results posted: 2019-09-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study