Japan
Tokyo and Other Japanese City, Japan
Completed
NCT Number: NCT01596088
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.
Completed
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Notify MeKey information
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Dexrazoxane
DrugPrimary outcomes
-
Adverse Events
Time frame: 4 weeks
Number of participants experienced adverse events
Sponsors and collaborators
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Industry
Registry information
Official study title
A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Important dates
- Primary completion
- 2014
- First posted
- May 10, 2012
- Registry last updated
- Apr 7, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.