A Study of Superoxide Dismutase Mimetic GC4419 for the reduction of Severe Oral Mucositis (SOM) in patients with head and neck cancer
- Conditions
- Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck CancerMedDRA version: 20.0Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2019-002745-38-GB
- Lead Sponsor
- Galera Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible for the study.
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. Planned radiation fields must include at least 2 oral sites (left and right buccal mucosa, floor of mouth, left and right lateral tongue, soft palate) with each site receiving a cumulative dose of at least 50 Gy.
Note: Unavoidable doses of at least 50 Gy, to include entrance, exit, and scatter doses, still constitute planned radiation.
3. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are 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). The decision on which cisplatin regimen to use in combination with IMRT and GC4419 will be at the discretion of the Investigator.
5. Age 18 years or older
6. Eastern Cooperative Oncology Group (ECOG) performance status = 2
7. Adequate hematologic function as indicated by:
- Absolute neutrophil counts (ANC) = 1,500/mm3
- Hemoglobin (Hgb) = 9.0 g/dL
- Platelet count = 100,000/mm3
8. Adequate renal and liver function as indicated by:
- Serum creatinine acceptable for treatment with cisplatin per institutional guidelines
- Total bilirubin = 1.5 x upper-normal limit (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
- Alkaline phosphatase = 2.5 x ULN
9. Serum pregnancy test negative for women of childbearing potential
10. Males and females must agree to use highly effective method of contraception starting prior to the first day of treatment and continuing after the last dose of GC4419 for 30 days (females) or 90 days (males)
11. Properly obtained written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Metastatic disease
2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemo-tolerance)
3. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially, not concurrently, with IMRT
4. Planned concurrent chemotherapy other than single agent cisplatin
5. Receiving any approved or investigational anti-cancer agent other than those provided for in this study
6. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days of first dose of GC4419
Note: Patients who are participating in non-interventional clinical studies (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
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
Note: Patients who have gastrostomy tubes prophylactically placed are eligible. Patients receiving supplemental nutrition through a gastrostomy tube at baseline may be eligible depending on diet.
9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating Investigator
10. Active infectious disease excluding oral candidiasis
11. Presence of oral mucositis at baseline. Subjects with mouth or throat pain solely due to postoperative effects are eligible, however.
12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
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.
16. Medical history that includes any condition, or requires the use of concomitant medications which, in the Investigator’s judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method