Status:
COMPLETED
Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanc...
Detailed Description
The drug being tested in this study is called alisertib. Alisertib is being tested in adult participants with advanced solid tumors or lymphomas. The study enrolled 26 participants. Participants will...
Eligibility Criteria
Inclusion
- 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
- Participant must meet protocol-specified laboratory values
- Suitable venous access
- Female participants 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 participants 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
- Prior or current investigational therapies within 4 weeks before the first dose of alisertib
- Female participants who are lactating or pregnant
- Participant 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 histamine (H2)-receptor antagonists
- Participant requiring systemic anticoagulation
- Ongoing nausea or vomiting that is Grade 2 or worse in intensity
- Known gastrointestinal (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
- Participant 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
Key Trial Info
Start Date :
July 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01898078
Start Date
July 16 2013
End Date
January 24 2017
Last Update
June 21 2019
Active Locations (3)
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1
The Bronx, New York, United States
2
Nashville, Tennessee, United States
3
San Antonio, Texas, United States