A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | August 2016 |
A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment
for the treatment of head and neck cancer.
for the treatment of head and neck cancer.
Inclusion Criteria:
- Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and
is planned to receive a standard course of concomitant CRT.
- Patients who have received surgery are eligible if surgery is performed within 6
weeks prior to study initiation.
- Planned to receive standard cisplatin chemotherapy administered either weekly or
every third week.
- Must be able to read and understand informed consent
- Adequate birth control methods for the duration of the study
Exclusion Criteria:
- Current mucositis.
- Prior radiation to the head and neck.
- Chemotherapy treatment within the previous 12 months.
- Tumors of the lips, sinuses, salivary glands or nasopharynx.
- Unknown primary tumor.
- Stage 4c metastases.
- Evidence of significant hepatic, hematologic, or immunologic disease.
- Women who are pregnant or breast-feeding.
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