NCT01596088

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 13, 2015

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

First QC Date

May 8, 2012

Results QC Date

February 27, 2015

Last Update Submit

March 18, 2015

Conditions

Extravasations of Anthracycline Anti-cancer Agents

Keywords

ExtravasationAnthracyclines

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of participants experienced adverse events

    4 weeks

Study Arms (1)

Drug: Dexrazoxane

EXPERIMENTAL

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)

Drug: Dexrazoxane

Interventions

DexrazoxaneDRUG
Drug: Dexrazoxane

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suspected to have been exposed to extravasation of anthracycline

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Interventions

Dexrazoxane

Intervention Hierarchy (Ancestors)

RazoxaneDiketopiperazinesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Development Division
Organization
Kissei Pharmaceutical Co., Ltd
rinsyousiken@pharm.kissei.co.jp

Study Officials

  • Tatsuro Takei

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Primary Completion

January 1, 2014

Last Updated

April 7, 2015

Results First Posted

March 13, 2015

Record last verified: 2015-03

Locations

JP(1)