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A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer

Phase 1
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer

Inclusion Criteria:

- Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell
carcinoma of the head and neck at the following sites: oral cavity, oropharynx,
hypopharynx and larynx with either:

- Stage IV p16 positive tumors and >10 pack-years smoking history.

- Stage III/IV p16 negative tumors, regardless of smoking history.

- At least evaluable disease; one measurable site of disease according to RECIST
(Version 1.1) criteria (at least 10 mm for conventional CT/MRI or spiral CT scan) is

- Subjects enrolled in the MTD expansion cohort must have at least 1 tumor lesion that
is suitable for repeat biopsy (pre- and post-CUDC-101 infusion).

- Age ≥ 18 years

- ECOG performance < 2

- Life expectancy ≥ 3 months

- If female, neither pregnant nor lactating

- If of child bearing potential, must use adequate birth control throughout the
participation in the treatment phase and for 60 days following the last study

- Absolute neutrophil count ≥ 1,800/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 8.0 g/dL,
creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤
2 x ULN.

- Serum magnesium and potassium within normal limits (may be supplemented to achieve
normal values)

- Able to render informed consent and to follow protocol requirements.

Exclusion Criteria:

- Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or
> 25% of marrow-bearing area.

- Prior chemotherapy for the current indication.

- Prior therapy that specifically and directly targets EGFR, HER2 or HDAC.

- Use of investigational agent(s) within 30 days prior to study treatment.

- Primary tumor site of nasopharynx, sinuses, or salivary gland.

- 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.

- Patients with prolonged QTc Interval >450 msec.

- Acquired Immune Deficiency Syndrome (AIDS) or known infection with human
immunodeficiency virus (HIV). Testing is not required.

- Known history of gastrointestinal bleeding, ulceration, or perforation within 6
months prior to study treatment.

- Known history of stroke or cerebrovascular accident within 6 months prior to study

- Symptomatic cardiac conduction abnormality within 12 months prior to study treatment.

- Prior history of hearing impairment.

- Known history of renal disease or ongoing renal impairment.

- Any uncontrolled condition (such as active systemic infection, diabetes,
hypertension), which in the opinion of the investigator, could affect the subjects
participation in the study.

- Prior allergic reaction to cisplatin, carboplatin or other platinum-containing

- Central nervous system metastases.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety and tolerability of CUDC-101 when administered in combination with concurrent cisplatin and radiation in subjects with locally advanced head and neck cancers.

Outcome Description:

Safety and tolerability will be assessed by the number of participants with adverse events and will determine the maxiumum tolerated dose of CUDC-101 in combination with cisplatin and radiation.

Outcome Time Frame:

18-24 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms



University of Colorado Cancer CenterDenver, Colorado  80262
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Stanford Cancer CenterStanford, California  94305-5824
Vanderbilt UniversityNashville, Tennessee  37232-6305
Henry Ford Health SystemDetroit, Michigan  48202
Overton Brooks VA Medical CenterShreveport, Louisiana  71101-4295