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BMX-001 with Chemoradiation in Head and Neck Cancer
NCT02990468Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2017
- Primary completion
- Feb 2020
- Countries
- 1
- Sponsor
- BioMimetix
- Modality
- Orthosteric Ligands, Light/Condition-Responsive Prodrugs
- Conditions
- head and neck cancer (HNC)
01
Overview
Phase 2, open-label, single-arm trial of manganese butoxyethyl pyridyl porphyrin in head and neck cancer (HNC), sponsored by BioMimetix. Primary endpoints: Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events at 1 year and Incidence Radiation-induced Mucositis by Clinician Scoring at 6 months. Started Apr 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Radiation Therapy, Cisplatin and BMX-001
Patients receive standard IMRT and Cisplatin plus subcutaneous BMX-001.
03
Who it enrols
Patients with pathologically confirmed Stage III-IVb squamous cell carcinoma of the head and neck undergoing definitive chemoradiation with cisplatin.
04
Endpoints
Primary
Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events
Incidence Radiation-induced Mucositis by Clinician Scoring
Secondary
Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production
Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production
Incidence of Radiation-induced Xerostomia by Clinician Scoring
Duration of Radiation-induced Mucositis
Impact on Radiation Dermatitis
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