drugset / Trial / NCT02369458
Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
RandomizedParallel-groupOpen-labelTreatment
Summary
No agent is known to have efficacy in patients with incurable HNSCC that progressed with prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this trial. Based on the preclinical and clinical data presented, the investigators propose that mitomycin C will have anti-tumor activity in these patients.
Timeline
- Start
- 2015-04-14
- Primary completion
- 2022-06-01
- Completion
- 2024-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | — | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |