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

NCT ID: NCT01171924

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: 5 days/week schedule

Group Type: EXPERIMENTAL

CUDC-101

Intervention Type: DRUG

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.

Arm B: 3 days/week schedule

Group Type: EXPERIMENTAL

CUDC-101

Intervention Type: DRUG

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.

Interventions

CUDC-101

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.

Intervention Type: DRUG

CUDC-101

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Curis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Diego Pacific Oncology and Hematology Associates

Encinitas, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Mountain Blue Global Cancer Care

Wheat Ridge, Colorado, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Lai CJ, Bao R, Tao X, Wang J, Atoyan R, Qu H, Wang DG, Yin L, Samson M, Forrester J, Zifcak B, Xu GX, DellaRocca S, Zhai HX, Cai X, Munger WE, Keegan M, Pepicelli CV, Qian C. CUDC-101, a multitargeted inhibitor of histone deacetylase, epidermal growth factor receptor, and human epidermal growth factor receptor 2, exerts potent anticancer activity. Cancer Res. 2010 May 1;70(9):3647-56. doi: 10.1158/0008-5472.CAN-09-3360. Epub 2010 Apr 13.

Reference Type: BACKGROUND

PMID: 20388807 (View on PubMed)

Related Links

http://www.curis.com

Curis, Inc. Company Website

Other Identifiers

CUDC-101-102

Identifier Type: -

Identifier Source: org_study_id