A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

Soligenix

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis

Treatments: Drug: Placebo; Drug: SGX942

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013050

IDR-OM-01

Details and patient eligibility

About

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
• Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
• Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
• Must be able to read and understand informed consent
• Adequate birth control methods for the duration of the study

Exclusion criteria

• Current mucositis.
• Prior radiation to the head and neck.
• Chemotherapy treatment within the previous 12 months.
• Tumors of the lips, sinuses, salivary glands or nasopharynx.
• Unknown primary tumor.
• Stage 4c metastases.
• Evidence of significant hepatic, hematologic, or immunologic disease.
• Women who are pregnant or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Control

Treatment:

Drug: Placebo

SGX942

Experimental group

Description:

Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg

Treatment:

Drug: SGX942