NCT01171924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 16, 2015

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

July 27, 2010

Results QC Date

April 23, 2015

Last Update Submit

February 1, 2016

Conditions

Head and Neck CancerLiver CancerBreast CancerGastric CancerNon-Small Cell Lung Cancer

Keywords

Head and Neck CancerLiver CancerBreast CancerGastric CancerNon-Small Cell Lung CancerEGFRHDACHer2CUDC-101

Outcome Measures

Primary Outcomes (1)

  • 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.

    12-15 months

Study Arms (2)

Arm A: 5 days/week schedule

EXPERIMENTAL
Drug: CUDC-101

Arm B: 3 days/week schedule

EXPERIMENTAL
Drug: CUDC-101

Interventions

CUDC-101DRUG

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 A: 5 days/week schedule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

San Diego Pacific Oncology and Hematology Associates

Encinitas, California, 92024, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Mountain Blue Global Cancer Care

Wheat Ridge, Colorado, 80033, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 20388807BACKGROUND

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsLiver NeoplasmsBreast NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

7-(4-(3-ethynylphenylamino)-7-methoxyquinazolin-6-yloxy)-N-hydroxyheptanamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Associate Director of Regulatory Affairs
Organization
Curis, Inc.
lsaunders@curis.com
(617) 503-6548

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 29, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 1, 2016

Results First Posted

October 16, 2015

Record last verified: 2016-02

Locations

US(7)