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

Phase 1

Completed

Conditions: Liver Cancer
Breast Cancer
Gastric Cancer
Non-Small Cell Lung Cancer
Head and Neck Cancer

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.

Recruitment & Eligibility

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.

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

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