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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines

NCT00548704

Extravasation

COMPLETED PHASE2/PHASE3

Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

NCT00548561

Anthracycline Extravasation

COMPLETED PHASE2/PHASE3

Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin

NCT03668639

Chemotherapy-induced Nausea and Vomiting Adverse Event Cervical Cancer

UNKNOWN PHASE2/PHASE3

Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

NCT02641938

Malignant Tumor

COMPLETED PHASE4

Study of HR20013 for Injection in Patients With Malignant Solid Tumors

NCT05465681

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extravasations of Anthracycline Anti-cancer Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Dexrazoxane

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexrazoxane

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No