Overview

This trial is active, not recruiting.

Conditions advanced solid tumors, lymphoma
Treatment mln8237
Phase phase 1
Target ARK-1
Sponsor Millennium Pharmaceuticals, Inc.
Start date July 2013
End date October 2014
Trial size 25 participants
Trial identifier NCT01898078, C14017

Summary

This is an open-label, multicenter, phase 1 study with the primary objective of evaluating the effect of food on the single-dose PK properties of alisertib administered as the ECT formulation. The secondary objective is to further evaluate the safety and tolerability of alisertib.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mln8237 alisertib
Patients will be randomly assigned in a crossover fashion to receive a single 50-mg dose of alisertib (administered as 5 x 10 mg enteric-coated tablets) with or without a standard high-fat breakfast on Day 1 of Cycle 1, with the respective alternate food intake condition (fasted to fed, or fed to fasted; n = approximately 9 per sequence) on Day 1 in Cycle 2.

Primary Outcomes

Measure
Ratio of geometric mean maximum plasma concentration (Cmax) of alisertib with food versus without food and associated 90% confidence intervals (CI)
time frame: Days 1 through 4 of Cycles 1 & 2
Ratio of geometric mean area under the plasma concentration versus time curve zero to the time of the last measurement (AUC0-last) of alisertib with food versus without food and associated 90% CI
time frame: Days 1 through 4 of Cycles 1 & 2
Ratio of geometric mean area under the plasma concentration versus time curve zero to infinity (AUC0-inf) of alisertib with food versus without food and associated 90% CI
time frame: Days 1 through 4 of Cycles 1 & 2

Secondary Outcomes

Measure
Evaluation of safety and tolerability of alisertib following single and multiple doses. Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs.
time frame: Recorded from first dose of study drug through 30 days after the last dose of study drug

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years or older - Histologically or cytologically confirmed advanced tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Patient must meet protocol-specified laboratory values - Female patients who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time or agree to practice true abstinence - Male patients who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to practice true abstinence Exclusion Criteria: - Prior or current investigational therapies within 4 weeks before the first dose of alisertib - Female patients who are lactating or pregnant - Patient requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib and during the study - Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor antagonists - Patient requiring systemic anticoagulation - Ongoing nausea or vomiting that is Grade 2 or worse in intensity - Known GI disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib - History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease - Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection - Patients who are lactose-intolerant or are unwilling/unable to consume the protocol specified standardized high-fat breakfast Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title An Open-Label, Phase 1, Two-Way, Cross-Over Study of the Effect of the Food on the Pharmacokinetics of MLN8237 (Alisertib) in Patients With Advanced Solid Tumors or Lymphomas
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Takeda.