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

NCT02369458

Phase 2 Completed 48 enrolled Washington University School of Medicine
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

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified
Background Pegfilgrastim Protein / enzyme biologic Subcutaneous