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

This study is currently recruiting participants.
Verified May 2012 by Kissei Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01596088
First received: May 8, 2012
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Extravasations of Anthracycline Anti-cancer Agents
 Drug: Dexrazoxane
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 4 weeks ]

Estimated Enrollment: 3
Arms Assigned Interventions
Experimental: Drug: Dexrazoxane Drug: Dexrazoxane

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596088

Contacts
Contact: Kissei Pharmaceutical Co., Ltd. rinsyousiken@pharm.kissei.co.jp

Locations
Japan
Japan Recruiting
Tokyo and Other Japanese City, Japan
Contact: Kissei Pharmaceutical Co., Ltd         rinsyousiken@pharm.kissei.co.jp    
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Tatsuro Takei Kissei Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01596088     History of Changes
Other Study ID Numbers: KDX1101
Study First Received: May 8, 2012
Last Updated: May 9, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Extravasation
Anthracyclines

Additional relevant MeSH terms:
Antineoplastic Agents
Razoxane
Therapeutic Uses
Pharmacologic Actions
 Cardiovascular Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013