At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Mitomycin-C +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
In Brief
A Phase 2 clinical trial evaluating Mitomycin-C and Pegfilgrastim for Squamous Cell Carcinoma of the Head and Neck and Squamous Cell Carcinoma, Head and Neck. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartApr 2015
Primary CompletionJun 2022
Study CompletionNov 2024
TodayJul 2026
First PostedFeb 24, 2015
Enrollment StartApr 14, 2015
Primary CompletionJun 1, 2022
Study CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 11.4 years ago
Interventions
Mitomycin-Cdrug
Pegfilgrastimdrug