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Head and Neck CancerPhase 1NCT01384799

Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer

A Phase 1 study testing CUDC-101, Cisplatin and Radiation Therapy in people with Head and Neck Cancer, run by Curis, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
CUDC-101, Cisplatin and Radiation Therapy
How many people
12 participants
Where
7 sitesUnited States
Study dates
Nov 2011to Oct 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 desirable.
  • 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
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  • 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 treatment.
  • 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.

Who cannot join

  • 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.
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  • 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 treatment.
  • 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 compounds.
  • Central nervous system metastases.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 01911

  • Overton Brooks VA Medical Center

    Shreveport, Louisiana, 71101

  • Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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

This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. 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 establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.

Being tested
CUDC-101, Cisplatin, Radiation Therapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CUDC-101Drug

    CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2.

  • CisplatinDrug

    Also called cisplatinum, CDDP, Platinol

    Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course.

  • Radiation TherapyRadiation

    The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants with adverse events.

    Safety and tolerability will be assessed by evaluating the number of patients with adverse events

    Measured: 18-24 months

Secondary outcomes (4)

  1. The number of subjects disease free at the completion of the treatment period.

    To evaluate the efficacy of CUDC-101 in combination with cisplatin and radiation therapy by evaluating the number of subjects disease free at the completion of the treatment period.

    Measured: 18-24 months

  2. The number of subjects disease free in the follow up period.

    To evaluate the efficacy of CUDC-101 in combination with cisplatin and radiation therapy by evaluating the number of subjects disease free in the follow up period.

    Measured: 18-24 months

  3. Concentration of CUDC-101 in the blood over time.

    Pharmacokinetics will involve a determination of the concentration of CUDC-101 in the blood over time.

    Measured: 18-24 months

  4. Number of circulating tumor cells pre treatment on Day -7 and 1 hour post treatment on Day -3.

    The ability of CUDC-101 to exert a biological effect on the tumor will be examined in pharmacodynamic samples.

    Measured: 18-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionSep 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01384799
Sponsor's protocol ID
CUDC-101-103
Status last verified
Feb 2018
First submitted
17 Jun 2011
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CUDC-101, Cisplatin and Radiation Therapy in people with Head and Neck Cancer, run by Curis, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants with adverse events. (time frame: 18-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01384799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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