Trial Outcomes & Findings for A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents (NCT NCT01596088)
NCT ID: NCT01596088
Last Updated: 2015-04-07
Results Overview
Number of participants experienced adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-04-07
Participant Flow
Participant milestones
| Measure |
Dexrazoxane
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Baseline characteristics by cohort
| Measure |
Dexrazoxane
n=2 Participants
|
|---|---|
|
Age, Customized
>=20 and <65 years
|
1 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksNumber of participants experienced adverse events
Outcome measures
| Measure |
Dexrazoxane
n=2 Participants
|
|---|---|
|
Adverse Events
|
2 participants
|
Adverse Events
Dexrazoxane
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexrazoxane
n=2 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2
|
Other adverse events
| Measure |
Dexrazoxane
n=2 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2
|
|
Investigations
Blood urea increased
|
50.0%
1/2
|
|
Investigations
Blood creatinine increased
|
100.0%
2/2
|
|
General disorders
Malaise
|
50.0%
1/2
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
50.0%
1/2
|
|
Infections and infestations
Pneumonia
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2
|
|
Nervous system disorders
Headache
|
100.0%
2/2
|
|
Immune system disorders
Hypersensitivity
|
50.0%
1/2
|
|
General disorders
Infusion site reaction
|
50.0%
1/2
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2
|
|
Investigations
Platelet count decreased
|
50.0%
1/2
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
Purpura
|
50.0%
1/2
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2
|
|
Investigations
Blood cholesterol increased
|
50.0%
1/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place