A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + IMRT for Locally Advanced Non-Metastatic SCC of the Oral Cavity/Oropharynx

Summary:

The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

Trial Description

Primary Outcome:

• Duration of Radiation Induced Severe Oral Mucositis per WHO Criteria, Through a Minimum of 60 Gy IMRT Delivered to the Tumour

Secondary Outcome:

• Safety of Low Dose vs. High Dose GC4419, Using the Adverse Event Scale: National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v4.0)
• Incidence of Radiation Induced Severe Oral Mucositis per WHO Criteria, Through a Minimum of 60 Gy IMRT Delivered to the Tumour
• Cumulative Incidence of Severe Oral Mucositis, per WHO Criteria for Entire Course of IMRT
• Time to Onset of Severe Oral Mucositis, per WHO Criteria
• Cumulative Incidence of Grade 4 Oral Mucositis, per WHO Criteria
• Duration of Severe Oral Mucositis, Per WHO Criteria
• GC4419's Effect on Tumour Response within 1 Year of IMRT Completion.

GT-201 is a randomized, double-blind, placebo-controlled, multi-centre study conducted in the U.S. to evaluate GC4419 administered IV for the reduction of incidence, duration, and severity of radiation induced oral mucositis in patients receiving cisplatin plus intensity-modulated radiation therapy for post-operative, or definitive treatment of locally advanced, non-metastatic squamous cell carcinoma of the head and neck, limited to the oral cavity or oropharynx. Patients will be randomized equally to 1 of 3 treatment arms: Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0

• 2.2 Gy) to a total of 60

• 72 Gy over approximately 7 weeks, plus cisplatin administered 80

• 100 mg/m2 once every three weeks for 3 doses or 30

• 40 mg/m2 once weekly for 6-7 doses (investigator's choice). Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0

• 2.2 Gy) to a total of 60

• 72 Gy over approximately 7 weeks, plus cisplatin administered 80

• 100 mg/m2 once every three weeks for 3 doses or 30

• 40 mg/m2 once weekly for 6-7 doses (investigator's choice). Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0

• 2.2 Gy) to a total of 60

• 72 Gy over approximately 7 weeks, plus cisplatin administered 80

• 100 mg/m2 once every three weeks for 3 doses or 30

• 40 mg/m2 once weekly for 6-7 doses (investigator's choice). Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy. All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral mucositis resolves to ≤ Grade 1. Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and complete requirements for primary endpoint analysis, which is defined as patients receiving a minimum cumulative dose of 60 Gy.

View this trial on ClinicalTrials.gov