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
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.
Checked against the public recordLast updated Mar 1, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Curis, Inc.
- Interventions being studied
- Drug: CUDC-101; Drug: CUDC-101
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Subjects with histopathologically confirmed diagnosis of advanced breast, gastric, head and neck, liver and non-small cell lung cancer. * 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 * 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 use supplements 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. * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- San Diego Pacific Oncology and Hematology AssociatesEncinitas, California
- The Angeles Clinic and Research InstituteLos Angeles, California
- Mountain Blue Global Cancer CareWheat Ridge, Colorado
- University of New Mexico Cancer CenterAlbuquerque, New Mexico
- Roswell Park Cancer InstituteBuffalo, New York
- Mary Crowley Cancer Research CentersDallas, Texas
- MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 1, 2016. Always confirm current availability with the study team.