Study of MLN8237 in Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated tablets (ECT), to characterize the multiple-dose safety, tolerability, and steady-state PK of alisertib administered as an OS, and to characterize the multiple-dose safety and tolerability of alisertib administered as an ECT.

Key facts

Study ID

NCT00962091

Run by

Millennium Pharmaceuticals, Inc.

People needed

53

Starts

2009-09-25

Expected to finish

2014-07-01

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each participant must meet all of the following inclusion criteria to be enrolled in the study:
• 18 years or older
• Histologically or cytologically confirmed metastatic and/or advanced solid tumor
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
• Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
• Voluntary written consent
• Suitable venous access for study-required blood sampling
• Measurable disease
• Recovered from effects of prior antineoplastic therapy
• Meet required entry laboratory and organ function levels

You may not qualify if…

• Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
• Female participants who are pregnant or lactating
• Serious medical or psychiatric illness that could interfere with protocol completion
• Major surgery within 14 days of first dose of alisertib
• Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of alisertib
• Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.
• Autologous stem cell transplant within 3 months before the first dose of alisertib, or prior allogeneic stem cell transplant at any time.
• Active infection requiring systemic therapy, or other serious infection
• Inability to swallow oral medication
• Gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of alisertib
• Symptomatic brain metastasis
• Uncontrolled cardiovascular condition
• Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• Lactose-intolerant (Parts A and B only)
• Prior history of metabolic acidosis (Parts A and B only)
• Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib
• A medical condition requiring use of pancreatic enzymes; or daily, chronic , or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists. Participants who intermittently use these medications must meet the following:
• No use of PPI within 7 days of first dose of alisertib
• No use of H2 antagonist or pancreatic enzymes within 24 hours of first dose of alisertib
• Participants requiring full systemic anticoagulation

Where it is running

• Premiere Oncology, A Medical Corporation — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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