Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Condition: Head and Neck Cancer; Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: Drug: GC4419; Intensity-modulated radiation therapy (IMRT); Cisplatin
Intervention description: GC4419 60 Minute Infusion; 2.0 to 2.2 Gy daily over 7 weeks; 100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses
Intervention MeSH terms: Avasopasem manganese
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: To evaluate the effects of GC4419 in subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in
      combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at
      high risk for Severe Oral Mucositis (SOM)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the
             head and neck that will be treated with cisplatin plus concurrent IMRT.

          2. Treatment plan to receive a continuous course of IMRT delivered as single daily
             fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.

          3. Patients who have had prior surgery may be eligible,

          4. Treatment plan to receive standard cisplatin monotherapy administered either every
             three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).

          5. Age 18 years or older

          6. ECOG performance status ≤ 2

          7. Adequate hematologic function

          8. Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN

        Exclusion Criteria:

          1. Metastatic disease

          2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites

          3. Prior induction chemotherapy or plans for chemotherapy to be administered only
             sequentially with IMRT

          4. Planned concurrent chemotherapy other than single agent cisplatin

          5. Receiving any approved or investigational anti-cancer agent

          6. Concurrent participation in another interventional clinical study

          7. Inability to eat soft solid food at baseline for reasons other than mouth soreness
             after surgery or dental procedures

          8. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at
             baseline

          9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years

         10. Active infectious disease excluding oral candidiasis

         11. Presence of oral mucositis at baseline.

         12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C

         13. Female patients who are pregnant or breastfeeding

         14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds

         15. Requirement for concurrent treatment with nitrates or other drugs that may, in the
             judgment of the treating Investigator, create a risk for a precipitous decrease in
             blood pressure.