Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT01171924

Recruitment Status:

Completed

Sponsor:

Curis, Inc.

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There are 7 Locations for this study

See Locations Near You

San Diego Pacific Oncology and Hematology Associates
Encinitas California, 92024, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
Mountain Blue Global Cancer Care
Wheat Ridge Colorado, 80033, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Mary Crowley Cancer Research Centers
Dallas Texas, 75230, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT01171924

Recruitment Status:

Completed

Sponsor:


Curis, Inc.

How clear is this clinincal trial information?

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