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Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors, Lymphoma

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Trial Information

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

- 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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to maximum plasma concentration

Outcome Description:

Pharmacokinetics of alisertib in plasma and total radioactivity in plasma and whole blood

Outcome Time Frame:

Daily for approximately 10 days

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

July 2013

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoma
  • Lymphoma



Comprehensive Clinical Development Tacoma, Washington  98418