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

Phase 1

Completed

• Conditions: Extravasations of Anthracycline Anti-cancer Agents
• Interventions: Drug: Dexrazoxane

• Registration Number: NCT01596088
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2014-01
• Results First Submitted: 2015-02-27
• Results First Submitted QC: 2015-02-27
• Status Verified: 2015-03
• Results First Posted: 2015-03-13
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug: Dexrazoxane	Dexrazoxane	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)

Primary Outcome Measures

Name	Time	Method
Adverse Events	4 weeks	Number of participants experienced adverse events

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan