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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

Primary Purpose

Head and Neck Cancer, Liver Cancer, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CUDC-101

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer, EGFR, HDAC, Her2, CUDC-101

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

San Diego Pacific Oncology and Hematology Associates
The Angeles Clinic and Research Institute
Mountain Blue Global Cancer Care
University of New Mexico Cancer Center
Roswell Park Cancer Institute
Mary Crowley Cancer Research Centers
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: 5 days/week schedule

Arm B: 3 days/week schedule

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.

Secondary Outcome Measures

Full Information

NCT ID

NCT01171924

First Posted

July 27, 2010

Last Updated

February 1, 2016

Sponsor

Curis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01171924

Brief Title

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

Official Title

A Phase Ib Open Label, Expansion Study to Investigate 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Curis, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer, EGFR, HDAC, Her2, CUDC-101

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: 5 days/week schedule

Arm Type

Experimental

Arm Title

Arm B: 3 days/week schedule

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CUDC-101

Intervention Description

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

Intervention Name(s)

CUDC-101

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.

Time Frame

12-15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

San Diego Pacific Oncology and Hematology Associates

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

The Angeles Clinic and Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Mountain Blue Global Cancer Care

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Mary Crowley Cancer Research Centers

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20388807

Citation

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.

Results Reference

background

Links:

URL

http://www.curis.com

Description

Curis, Inc. Company Website

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