A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

The drug being tested in this study is called alisertib. Alisertib is being tested in adult
patients with advanced solid tumors or relapsed refactory lymphoma. The study will look at
the effect of the pharmacokinetics (how the drug moves through the body) of alisertib in the
presence and absence of itraconazole.

This is an open label study. Participants will receive:

- Alisertib tablets 30 mg in Part A and 50 mg in Part B

- Itraconazole oral solution 200 mg in Part A

Participation in Part A is 14 days. The maximum duration of treatment with alisertib will be
12 months (approximately 16 cycles) unless it is determined by the investigator, with
agreement by the sponsor, that a patient would derive clinical benefit from continued
treatment beyond 12 months.

This multi-centre study will take place in the United States.

Inclusion Criteria

1. Male and female patients 18 years of age or older.

2. Patients with histologic or cytologic diagnosis of advanced or metastatic solid
tumors or lymphomas for which no curative or life-prolonging therapies exist.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1. Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be
discontinued at least 14 days before the first dose of alisertib, and the use of
these agents is not permitted during the study (except for the protocol-specified
administration of itraconazole).

2. Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or
GI procedure that could interfere with or modify the oral absorption or tolerance of
alisertib.

3. Known hypersensitivity or intolerance to itraconazole or similar class agents.