drugset / Trial / NCT02901483
A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
Summary
It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck squamous cell carcinoma (HNSCC) patients. * Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503. * Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18 additional patients will be enrolled at the recommended volume level to evaluate for safety and efficacy.
Timeline
- Start
- 2016-10-11
- Primary completion
- 2020-08-17
- Completion
- 2020-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | HAFNIUM OXIDE | Other / unclassified | 5 % | Other |
| Subject | HAFNIUM OXIDE | Other / unclassified | 10 % | Other |
| Subject | HAFNIUM OXIDE | Other / unclassified | 15 % | Other |
| Subject | HAFNIUM OXIDE | Other / unclassified | 22 % | Other |
| Subject | HAFNIUM OXIDE | Other / unclassified | 33 % | Other |