Status:
COMPLETED
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Relapsed/Refractory Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02259010
Start Date
October 22 2014
End Date
October 21 2016
Last Update
September 20 2019
Active Locations (4)
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1
St Louis, Missouri, United States
2
Oklahoma City, Oklahoma, United States
3
Germantown, Tennessee, United States
4
Dallas, Texas, United States