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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the safety and tolerability of CUDC-101 in subjects with advanced solid tumors (breast, gastric, head and neck, liver, and non-small cell lung cancer) when administered at the MTD on either a 5 days/week schedule or 3 days/week schedule.

Outcome Description:

Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events, dose reductions, and patient compliance will be compared.

Outcome Time Frame:

12-15 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CUDC-101-102

NCT ID:

NCT01171924

Start Date:

July 2010

Completion Date:

Related Keywords:

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

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Mary Crowley Cancer Research CentersDallas, Texas  75201
San Diego Pacific Oncology and Hematology AssociatesEncinitas, California  92024
Mountain Blue Global Cancer CareWheat Ridge, Colorado  80033