To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

Inclusion Criteria:

- Patients must have histologic or cytologic evidence of a solid neoplasm for which no
standard therapy is available, or have progressed despite standard therapy, or are
intolerant to standard therapy.

- Patients must have evidence of recurrent, locally advanced, or metastatic disease.

- Patients can either have had no prior anticancer therapy, multiple lines of either
prior chemotherapy/biologic therapy/experimental therapy or, if the patient has
anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior
crizotinib.

- Patients must have a predicted life expectancy of more than 3 months.

- Patients must have presence of at least 1 lesion that is measurable or evaluable
using RECIST v1.1.

- Patients must have an ECOG performance score of 0, 1, or 2.

- Patients with central nervous system (CNS) metastases will be allowed on this study.
Patients may have received surgical and/or radiation treatment. The metastases must
be neurologically stable, on or off corticosteroids. Patients can have low level,
asymptomatic brain lesions that do not require surgical/radiation intervention
acutely. Patients with symptomatic lesions with impending neurologic compromise
should be appropriately treated with high dose steroids/radiation and may be
re-evaluated for this study when neurologically stable.

- Patients must have completed any prior anticancer treatment and must have recovered
from any acute toxicities. The period between the last dose of prior treatment and
the first dose of study drug treatment must be at least 1 week for radiotherapy and
at least 2 to 3 weeks for all other modalities of therapy including chemotherapy,
monoclonal antibody therapy, immunotherapy, other investigational drugs, or other
kinase inhibitors.

- Other criteria apply.

Exclusion Criteria:

- The patient has ongoing or active infection requiring parenteral antibiotics.

- The patient has uncontrolled hypertension despite adequate therapy (ie, systolic
blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg
found on 2 separate occasions separated by 1 week).

- The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and
occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the
first dose of study drug.

- The patient has an active second malignancy other than curatively resected basal cell
carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the
cervix, or other cancers for which they are treated with curative intent, and no
known active disease in the 3 years prior to enrollment.

- The patient has a primary brain tumor. Patients may have brain metastases from
another primary site.

- The patient has QTcF interval greater than 450 msec, has a known history of QTcF
prolongation, is taking medications known to prolong QTcF, or has a history of
torsade de pointes.

- The patient has a prior ALK-inhibitor-related toxicity or any other prior
therapy-related acute toxicity that has not resolved prior to the first dose of study
drug.

- Other criteria apply.