Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

• Status: Completed
• Trial end date: 2013-06-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

Each participants 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 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.

• Expected survival longer than 3 months from enrollment in the study.

• Radiographically or clinically evaluable tumor.

• Suitable venous access for the conduct of blood sampling.

• Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy).

• 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.

• 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 abstain from heterosexual intercourse.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

• Female participants who are lactating or have a positive serum pregnancy test.

• Treatment with any investigational products or systemic antineoplastic treatment within 21 days before the first dose of alisertib.

• 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 within 24 hours preceding the first dose of alisertib.

• Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices). Low molecular weight heparin, administered as preventive treatment, is allowed if the participant has tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.

• Major surgery within the 14 days preceding the first dose of alisertib.

• Infection requiring systemic intravenous (IV) antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.

• Life-threatening or uncontrolled medical illness unrelated to cancer.

• Ongoing nausea or vomiting that is Grade 2 or worse in intensity.

• Diarrhea that is Grade 2 or worse in intensity or use of an antimotility agent to control diarrhea to an intensity of Grade 1 or lower level.

• Known GI disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib.

• History of urinary and/or fecal incontinence.

• History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease.

• Inability to swallow tablets, or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medications for 2 hours before and 1 hour after the first dose of alisertib.

• Inadequate bone marrow or other organ function as specified in study protocol.

• Any cardiovascular condition specified in the study protocol.

• Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.

• Inability to comply with study visits and procedures including required inpatient confinement (approximately 11-17 days).

Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.