A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies

Inclusion Criteria:

- Subjects with neoplastic disease refractory to currently available therapies or for
which no effective treatment is available

- Subjects with life expectancy of 12 weeks or longer.

- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
2.

Exclusion Criteria:

- Subjects who received any anti-cancer medications in the 21 days prior to receiving
their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.

- Subjects with history of brain metastases or spinal cord compression.

- Subjects who have undergone a bone marrow or solid organ transplant.

- Subjects who have had major surgery within 4 weeks prior to study entry or had minor
surgical procedure within 7 days prior to initiating treatment.

- Subjects with a history of any gastrointestinal condition

- Is receiving any compound that is known to be a potent inducer or inhibitor of CYP3A4

- Subjects with an active autoimmune process or is receiving therapy for an autoimmune
disease

- Subjects treated with a serotonin reuptake inhibitor within 3 weeks prior to study
entry