Overview

This trial is active, not recruiting.

Conditions advanced solid tumors, relapsed/refractory lymphoma
Treatments alisertib, itraconazole
Phase phase 1
Target ARK-1
Sponsor Millennium Pharmaceuticals, Inc.
Start date October 2014
End date April 2016
Trial size 24 participants
Trial identifier NCT02259010, C14020

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Alisertib 30 mg, tablets, orally, on Day 1 and Day 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13.
alisertib
Alisertib tablets
itraconazole SPORANOX®
Itraconazole oral solution
(Experimental)
Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21 day cycles until disease progression or unacceptable toxicity.
alisertib
Alisertib tablets

Primary Outcomes

Measure
Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
AUC(0-last): Area Under the Plasma Concentration Curve from Time Zero to the Time of the Last Quantifiable Concentration of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
AUC(0-inf): Area under the Plasma Concentration Curve from Time Zero to Infinity of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)

Secondary Outcomes

Measure
CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
Tmax:Time to Achieve Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
T½: Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
Cmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
Tmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
AUC(0-last) of Alisertib metabolites M1 and M2 of Alisertib in Presence and Absence of Itraconazole in Part A
time frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Day 1 to 30 Days post last dose
Number of Participants with Markedly Abnormal Laboratory Values
time frame: Day 1 to 30 Days post last dose
Change from Baseline in Weight
time frame: Day 1 to 30 Days post last dose
Change from Baseline in Vital Sign Measurements
time frame: Day 1 to 30 Days Post Last Dose

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria 1. Male and female patients 18 years of age or older. 2. Patients with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria 1. 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). 2. 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. 3. Known hypersensitivity or intolerance to itraconazole or similar class agents.

Additional Information

Official title 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
Description The drug being tested in this study is called alisertib. Alisertib is being tested in adult patients 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 14 days. 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 patient would derive clinical benefit from continued treatment beyond 12 months. This multi-centre study will take place in the United States.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc..