A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

Curis

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

Drug: CUDC-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00728793

CUDC-101-101

Details and patient eligibility

About

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
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 be supplement 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. 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
- Warfarin