Phase 2
N=2
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Extravasations of Anthracycline Anti-cancer Agents
Bottom Line
View on ClinicalTrials.gov: NCT01596088 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Mar 2015
Primary outcome: Primary: Adverse Events — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexrazoxane (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01596088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.