Status:
COMPLETED
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors
Lead Sponsor:
Curis, Inc.
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00728793
Start Date
August 1 2008
End Date
April 1 2010
Last Update
February 22 2018
Active Locations (2)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, United States, 78229