Phase 1
Completed N=26
Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
Source: ClinicalTrials.gov NCT01898078 ↗Enrolled (actual)
26
Serious AEs
53.8%
Results posted
Jun 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration of Alisertib — 1338.6; 1354.5 nM
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 advanced solid tumors or lymphomas.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration of Alisertib |
1338.6; 1354.5 | — |
| PRIMARY AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib |
24645.5; 20797.7 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib |
24537.5; 22771.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
13; 13; 7; 7 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs |
10; 8; 5; 3; 5; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs |
0; 1; 0; 1; 0; 1 | — |
Eligibility Criteria
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
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01898078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.