A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/10/2018 |
| Start Date: | October 2018 |
| End Date: | October 2024 |
| Contact: | Jeffrey M Brill |
| Email: | info@galeratx.com |
| Phone: | (610) 725-1500 |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
