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CompletedNCT01596088Updated Apr 7, 2015Results posted

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

A Phase 1/2 interventional study of Dexrazoxane in Extravasations of Anthracycline Anti-cancer Agents, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
2
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Extravasations of Anthracycline Anti-cancer Agents

Keywords

  • Extravasation
  • Anthracyclines
03

In context

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All

Inclusion criteria

  • Patients suspected to have been exposed to extravasation of anthracycline

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Drug: 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)

    Drug: Dexrazoxane

Interventions

  • DrugDexrazoxane
06

What researchers measure

Primary outcomes

  1. Adverse Events

    Number of participants experienced adverse events

    Time frame: 4 weeks

07

Results

Posted Mar 13, 2015

Participant flow

Participant flow — Overall Study
MilestoneDexrazoxane
Started2
Completed2
Not completed0

Outcome measures

PrimaryAdverse Events

Number of participants experienced adverse events

Time frame:
4 weeks
Reported as:
Number · participants
Adverse Events
participantsDexrazoxane
Adverse Events2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dexrazoxane—1/2 (50%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventDexrazoxane
Febrile neutropeniaBlood and lymphatic system disorders1/2
Most frequent other events
Showing 10 of 19
Most frequent other events
EventDexrazoxane
NauseaGastrointestinal disorders2/2
Blood creatinine increasedInvestigations2/2
HeadacheNervous system disorders2/2
ConstipationGastrointestinal disorders1/2
Blood urea increasedInvestigations1/2
MalaiseGeneral disorders1/2
PleurisyRespiratory, thoracic and mediastinal disorders1/2
PneumoniaInfections and infestations1/2
AnaemiaBlood and lymphatic system disorders1/2
HypersensitivityImmune system disorders1/2

Baseline characteristics

Age, Customized
Age, Customized(participants)Dexrazoxane
>=20 and <65 years1
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)Dexrazoxane
Female1
Male1
08

Study locations

1 site
  • Japan
    Tokyo and Other Japanese City, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01596088
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 10, 2012
Primary completion
Jan 2014
Results posted
Mar 13, 2015
Last update
Apr 7, 2015

Study contacts

Tatsuro Takei
study director · Kissei Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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