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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Relapsed/Refractory Lymphoma

In brief

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

Key facts

Study ID

NCT02259010

Run by

Millennium Pharmaceuticals, Inc.

People needed

24

Starts

2014-10-22

Expected to finish

2016-10-21

Last updated by the study team

2019-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants 18 years of age or older.
• Participants with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if…

• Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be discontinued at least 14 days before the first dose of alisertib, and the use of these agents is not permitted during the study (except for the protocol-specified administration of itraconazole).
• Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib.
• Known hypersensitivity or intolerance to itraconazole or similar class agents.

Where it is running

• Study site — St Louis, Missouri, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Germantown, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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