Trials / Completed
CompletedNCT02369458
Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitomycin-C | |
| DRUG | Pegfilgrastim |
Timeline
- Start date
- 2015-04-14
- Primary completion
- 2022-06-01
- Completion
- 2024-11-01
- First posted
- 2015-02-24
- Last updated
- 2025-11-18
- Results posted
- 2023-05-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02369458. Inclusion in this directory is not an endorsement.