The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the 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.
Active, not recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| GC4419 | GC4419 | |
| Placebo | Placebo |
| Name | Type | Description | Interventions |
|---|---|---|---|
| GC4419 | Experimental |
| |
| Placebo | Placebo Comparator |
|
Inclusion Criteria:
- squamous cell carcinoma of the head and neck
- treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy
with a cumulative radiation dose of 60-72 Gy
- Treatment plan to receive standard cisplatin monotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematologic, renal and liver function
- Negative serum pregnancy test
- Use of effective contraception
Exclusion Criteria:
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical
- Prior induction chemotherapy
- Receiving any approved or investigational anti-cancer agent other than those provided
for in this study
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline
- Malignant tumors other than HNC within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline
- Known history of HIV or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a
risk for a precipitous decrease in blood pressure
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Cumulative incidence of severe OM |
| Time Frame: | From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks. |
| Safety Issue: | |
| Description: |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Galera Therapeutics, Inc. |
August 26, 2021
