- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938080
Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck
A Phase 1b, Multi-center, Single Blinded, Placebo-controlled, Sequential Dose Escalation Study to Assess the Safety and Tolerability of Topically Applied AG013 in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to investigate the safety and tolerability of AG013 in subjects who are at risk for oral mucositis (OM) and to assess clinical efficacy of AG013 in the reduction of signs and symptoms of OM in patients receiving induction chemotherapy for the treatment of their head and neck cancer.
AG013 is made up of genetically modified (GM) bacteria called Lactococcus lactis (L. lactis). Wild type L. lactis are commonly used to produce dairy products including cheeses and milk. To make AG013, the DNA of L. lactis has been changed in the laboratory to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted in saliva and intestines. Trefoil factors have been shown to be important in protecting and healing mucosal tissues, such as the tissue in the mouth, when these tissues are damaged by cancer therapies such as chemotherapy and radiation therapy.
The proposed Phase 1b clinical trial will enroll subjects with head and neck cancer who develop OM during their first cycle of treatment with induction chemotherapy. OM is a painful, common toxicity of many forms of drug and radiation therapy used for the treatment of cancer. Subjects with OM get soreness, irritation, and ulcers in the mouth and may have difficulties eating, drinking or swallowing as a result of their cancer treatment.
During the second cycle of induction chemotherapy, eligible subjects will receive AG013 or placebo for 14 consecutive days at a frequency of one rinse, three rinses or six rinses per day (sequential dose escalation design).
At least 21 subjects will be enrolled in the study. For each of the three daily dose levels, 5 subjects will be assigned to AG013 (n=5) and 2 subjects will be assigned to placebo (n=2).
Throughout the study, safety will be monitored by collecting and recording Adverse Events, laboratory assessments and the presence of sAGX0085 bacteria in blood.
An independent Data Safety Monitoring Board (DSMB) will be constituted before the enrollment of subjects in order to review safety data from each enrollment group.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Ingram Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing and able to understand and sign the study specific Informed Consent Form (ICF) approved by the site's Institutional Review Board
- Males or females 18 years or older
- Recently diagnosed with pathologically-confirmed squamous cell carcinoma of the head and neck (e.g., oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, lips, sinuses, salivary glands, unknown primary)
- Planned to receive at least two cycles of induction chemotherapy of the same regimen consisting of cisplatin/fluorouracil (PF) or cisplatin/fluorouracil/docetaxel (PFT). The planned CT cycles must be of the same length and must be a minimum of 14 days in length
- Karnofsky performance score ≥ 60%
- Screening laboratory assessments:
- Hemoglobin ≥ 10g/dl
- White blood count ≥ 3500 cells/mm3
- Absolute neutrophil counts ≥ 1500 cells/ mm3
- Direct bilirubin ≤ 2x upper limit of normal (ULN)
- Serum AST and ALT ≤ 3 x ULN
- Serum creatinine ≤ 2 mg/dl
- Serum pregnancy test: negative for females of childbearing potential: A women is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
- Subjects of childbearing potential must agree to utilize effective contraceptive methods of birth control during study participation and for 30 days following the last treatment with IMP
- Have documented mouth pain during CT Cycle 1 (i.e., OMDQ question 2 score of ≥ 2 during CT Cycle 1)
Exclusion Criteria:
- Prior radiation to the head and neck
- Chemotherapy within 21 days prior to study start
- Presence of active infectious disease excluding oral candidiasis
- Current use of antibiotic rinses or troches
- Alcohol abuse syndrome; recovered alcoholics may be included
- Presence of OM (WHO Grade > 0)
- Chronic immunosuppression
- Known seropositive for HIV or hepatitis B or C
- Use of investigational agent within 30 days of signing informed consent
- Teeth extractions within 7 days prior to the start of CT administration
- Female subjects who are pregnant or nursing
- Known sensitivity to any investigational agent
- Inability to give informed consent or comply with study requirements
- Unwilling or unable to complete subject diary
- Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits
Study Plan
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AG013: one mouth rinse/day
|
Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
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EXPERIMENTAL: AG013: three mouth rinses/day
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Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
|
EXPERIMENTAL: AG013: six mouth rinses/day
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Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
|
PLACEBO_COMPARATOR: one mouth rinse/day
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Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
|
PLACEBO_COMPARATOR: three mouth rinses/day
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Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
|
PLACEBO_COMPARATOR: six mouth rinses/day
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Mouth rinse once a day for 14 days
Mouth rinse three times a day for 14 days
Mouth rinse six times a day for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (Adverse Events, laboratory assessments and the presence of sAGX0085 bacteria in blood)
Time Frame: 16 months
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Up to 16 months
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16 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of serum samples, buccal smears and saliva samples
Time Frame: 28 days
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Day 1 CT cycle 2, Day 7 CT cycle 2, Day 14 CT cycle 2, End of Study
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28 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara A Murphy, MD, Vanderbilt-Ingram Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG013-ODOM-101
- RAC0810-942
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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