A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Phase 1/Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Extravasations of Anthracycline Anti-cancer Agents
Both
Extravasations of Anthracycline Anti-cancer Agents
Trial Information
A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Inclusion Criteria:
- Patients suspected to have been exposed to extravasation of anthracycline
Exclusion Criteria:
- Patients reasonably suspected to have been exposed to extravasation by other
compounds than anthracyclines through the same IV access, e.g. vincristine,
mitomycin, and vinorelbine, all of which may cause ulceration
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse Events
Outcome Time Frame:
4 weeks
Principal Investigator
Tatsuro Takei
Investigator Role:
Study Director
Investigator Affiliation:
Kissei Pharmaceutical Co., Ltd.
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
KDX1101
NCT ID:
NCT01596088
Start Date:
Completion Date:
Related Keywords:
- Extravasations of Anthracycline Anti-cancer Agents
- Extravasation
- Anthracyclines
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