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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01596088
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extravasations of Anthracycline Anti-cancer Agents	Drug: Dexrazoxane	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• 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
• Actual Primary Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Adverse Events [4 weeks]

   Number of participants experienced adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Japan	Tokyo and Other Japanese City		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

• Study Director: Tatsuro Takei, Kissei Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01596088
• Other Study ID Numbers: KDX1101
• First Posted: May 10, 2012
• Last Update Posted: Apr 7, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Extravasation; Anthracyclines
• Additional relevant MeSH terms: Dexrazoxane; Razoxane

Study Results

Participant Flow

Arm/Group Title	Dexrazoxane
Arm/Group Description
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dexrazoxane
Arm/Group Description
Overall Participants	2
Age, Customized (participants) [Number]
>=20 and <65 years	1 50%
>=65 years	1 50%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	Number of participants experienced adverse events
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexrazoxane
Arm/Group Description
Measure Participants	2
Number [participants]	2 100%

Adverse Events

Arm/Group Title	Dexrazoxane
Arm/Group Description
All Cause Mortality
	Dexrazoxane
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dexrazoxane
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Blood and lymphatic system disorders
Febrile neutropenia	1/2 (50%)
Other (Not Including Serious) Adverse Events
	Dexrazoxane
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Blood and lymphatic system disorders
Anaemia	1/2 (50%)
Gastrointestinal disorders
Constipation	1/2 (50%)
Nausea	2/2 (100%)
General disorders
Malaise	1/2 (50%)
Infusion site reaction	1/2 (50%)
Immune system disorders
Hypersensitivity	1/2 (50%)
Infections and infestations
Pneumonia	1/2 (50%)
Investigations
Blood urea increased	1/2 (50%)
Blood creatinine increased	2/2 (100%)
Aspartate aminotransferase increased	1/2 (50%)
Lymphocyte count decreased	1/2 (50%)
Platelet count decreased	1/2 (50%)
Neutrophil count decreased	1/2 (50%)
White blood cell count decreased	1/2 (50%)
Blood cholesterol increased	1/2 (50%)
Nervous system disorders
Headache	2/2 (100%)
Respiratory, thoracic and mediastinal disorders
Pleurisy	1/2 (50%)
Skin and subcutaneous tissue disorders
Purpura	1/2 (50%)
Alopecia	1/2 (50%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.