Food Effect Study of Alisertib (MLN8237) in Patients With Advanced Solid Tumors or Lymphomas
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | May 2016 |
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
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.
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.
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
We found this trial at
3
sites
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