A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Kissei

Status and phase: Completed; Phase 2; Phase 1

Conditions: Extravasations of Anthracycline Anti-cancer Agents

Treatments: Drug: Dexrazoxane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01596088

KDX1101

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

Drug: Dexrazoxane

Experimental group

Description:

Dexrazoxane should be given once daily for 3 consecutive days. The dose is: Day 1: 1000 mg/m2, Day 2: 1000 mg/m2, Day 3: 500 mg/m2 (body surface area)

Treatment:

Drug: Dexrazoxane