Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:June 2015
Contact:Shadreck M Mareya
Email:info@sucampo.com
Phone:301-961-3400

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A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

To evaluate the efficacy, safety, and pharmacokinetics (PK) of liquid cobiprostone in
preventing oral mucositis, when administered topically to the oral mucosa via spray for the
duration of radiation and chemotherapy (RT/CT).


Inclusion Criteria:

- Recently-diagnosed (within the last 6 months), histologically-documented,
non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable
to radiotherapy with concurrent chemotherapy as the definitive treatment modality.

- Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose
administered via continuous course of external beam irradiation to the oral cavity
and/or oropharynx via intensity-modulated radiation therapy [IMRT] and/or
image-guided radiation therapy [IGRT], combined with conventional or
weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.

Exclusion Criteria:

- Subject has received prior radiation to the head and neck region (+/- chemotherapy).

- Subject has had any other prior invasive malignancy, unless disease-free for a
minimum of 3 years.

- Subject has metastatic disease (M1) Stage IV-C.

- Subject has a presence of mucosal ulceration or oral mucositis at screening or
develops this prior to randomization, and/or has unhealed wounds remaining from
surgical resection and/or excisional biopsy procedure.

- Subject is using a pre-existing feeding tube for nutritional support at study entry.
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