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

Completed · Phase 1

Conditions studied: Tumors

In brief

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.

Key facts

Study ID

NCT00728793

Run by

Curis, Inc.

People needed

25

Starts

2008-08-01

Expected to finish

2010-04-01

Last updated by the study team

2018-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Karmanos Cancer Institute — Detroit, Michigan, United States
• START (South Texas Accelerated Research Therapeutics) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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