Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas
Inclusion Criteria:
Each patient 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 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
- 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 abstain from
heterosexual intercourse
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:
- Female patients 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.
- Patient 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 patient 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.