A Phase I Open Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Subjects With Advanced and Refractory Solid Tumors
1. Subjects with a histopathologically confirmed diagnosis of advanced solid tumor.
2. Subjects must have no further standard of care options.
3. Measurable or non-measurable disease
4. Age ≥ 18 years
5. ECOG performance status ≤ 2
6. Life expectancy ≥ 3 months
7. Women of child bearing potential must have a negative serum pregnancy test.
8. Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; creatinine ≤ 1.5x upper
limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. For subjects
with documented liver metastases, the AST/ALT may be ≤ 5x ULN
9. Serum magnesium and potassium within normal limits (may be supplemented to achieve
10. Subjects with brain metastases are eligible if controlled on a stable dose of ≤ 10mg
prednisone/day or its equivalent dose of steroids.
11. Men and women of child bearing potential must agree to use adequate birth control
throughout their participation in the study and for 60 days following the last study
12. Able to provide written informed consent and to follow protocol requirements.
1. Systemic anticancer therapy within 28 days prior to study treatment. Subjects with
prostate cancer on LHRH hormonal therapy may be enrolled and continue on this
2. Use of any investigational agent(s) within 21 days prior to study treatment.
3. Known human immunodeficiency virus (HIV) positive, hepatitis B surface
antigen-positive, or known or suspected active hepatitis C infection.
4. Subjects receiving moderate or strong CYP3A4 or CYP2D6 inhibitors within 7 days prior
to study treatment (See Appendix C for examples).
5. Serious infection requiring systemic antibiotic therapy within 14 days prior to study
6. Known gastrointestinal condition that would interfere with swallowing or the oral
absorption or tolerance of CUDC-101.
7. Ongoing diarrhea of any grade (per NCI CTCAE v4.03).
8. Uncontrolled or severe cardiovascular disease, including myocardial infarct or
unstable angina within 6 months prior to study treatment, New York Heart Association
(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring
medication for treatment, clinically significant pericardial disease, or cardiac
9. Unstable or clinically significant concurrent medical condition that would, in the
opinion of the Investigator, jeopardize the safety of a subject and/or their
compliance with the protocol.