A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

Inclusion Criteria:

- Subjects with histopathologically confirmed diagnosis of advanced breast, gastric,
head and neck, liver and non-small cell lung cancer.

- For subjects with non-small cell lung cancer only:

- Most recent treatment must be erlotinib and subjects must have had a
radiographic partial or complete response to treatment as defined by RECIST
criteria and should be currently progressing after the documented response.

- A documented mutation in EGFR exons 19 or 21

- Subjects must have no further standard of care options or have refused standard
therapy

- Measurable or evaluable disease

- Age ≥ 18 years

- ECOG performance < 2

- Life expectancy ≥ 3 months

- If female, neither pregnant or lactating

- If of child bearing potential, must use adequate birth control

- Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;

- Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥
60mL/min/1.73m2

- Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver
metastases, the AST/ALT may be ≤ 5x ULN

- Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation

- Serum magnesium and potassium within normal limits (may use supplements to achieve
normal values)

- Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg
prednisone/day or its equivalent dose of steroids

- Able to render informed consent and to follow protocol requirements.

Exclusion Criteria:

- Anticancer therapy within 4 weeks of study entry.

- Use of investigational agent(s) within 30 days of study entry

- History of cardiac disease with a New York Heart Association (NYHA) Class II or
greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina
in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring
medication for treatment.

- Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
Subjects with liver cancer and hepatitis may be eligible.