A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
- Conditions
- Liver CancerBreast CancerGastric CancerNon-Small Cell Lung CancerHead and Neck Cancer
- Interventions
- Registration Number
- NCT01171924
- Lead Sponsor
- Curis, Inc.
- Brief Summary
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer 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 compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer.
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For subjects with non-small cell lung cancer only:
- Most recent treatment must be erlotinib and subjects must have had a radiographic partial or complete response to treatment as defined by RECIST criteria and should be currently progressing after the documented response.
- A documented mutation in EGFR exons 19 or 21
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Subjects must have no further standard of care options or have refused standard therapy
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Measurable or evaluable disease
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Age ≥ 18 years
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ECOG performance < 2
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Life expectancy ≥ 3 months
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If female, neither pregnant or lactating
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If of child bearing potential, must use adequate birth control
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Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
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Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
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Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
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Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
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Serum magnesium and potassium within normal limits (may use supplements to achieve normal values)
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Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
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Able to render informed consent and to follow protocol requirements.
- Anticancer therapy within 4 weeks of study entry.
- 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. Subjects with liver cancer and hepatitis may be eligible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: 5 days/week schedule CUDC-101 - Arm B: 3 days/week schedule CUDC-101 -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 12-15 months Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
Mountain Blue Global Cancer Care
🇺🇸Wheat Ridge, Colorado, United States
San Diego Pacific Oncology and Hematology Associates
🇺🇸Encinitas, California, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States