We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596088
First Posted: May 10, 2012
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
  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: Masking: None (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:


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

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 4 weeks ]
    Number of participants experienced adverse events


Enrollment: 2
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596088


Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Tatsuro Takei Kissei Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01596088     History of Changes
Other Study ID Numbers: KDX1101
First Submitted: May 8, 2012
First Posted: May 10, 2012
Results First Submitted: February 27, 2015
Results First Posted: March 13, 2015
Last Update Posted: April 7, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Dexrazoxane
Razoxane
Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimitotic Agents
Mitosis Modulators