Extravasations of Anthracycline Anti-cancer Agents Clinical Trial
Official title:
A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
| NCT number | NCT01596088 |
| Other study ID # | KDX1101 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| First received | May 8, 2012 |
| Last updated | March 18, 2015 |
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.
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Japan | Tokyo and Other Japanese City |
| Lead Sponsor | Collaborator |
|---|---|
| Kissei Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse Events | Number of participants experienced adverse events | 4 weeks | Yes |