CompletedPhase 1NCT01171924

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

StatusCompleted
PhasePhase 1
U.S. locations7
SponsorCuris, Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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