A Phase I Open-Label, Multiple Dose, Sequential Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced and Refractory Solid Tumors
- Subjects with advanced, refractory solid tumors and a histopathologically confirmed
- Subjects must have no further standard of care options or have refused standard
- 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 ≥
- 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 be supplement to achieve
- 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.
- Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH
hormonal therapy may be enrolled and continue on this therapy.
- 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.
- The following are permitted but should be used with caution and other suitable agents
used if possible:
- Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
- CYP3A4 inducers
- CYP3A4 inhibitors