Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease MedDRA version: 9.1 Level: LLT Classification code 10017533 Term: Fungal infection MedDRA version: 12.1 Level: HLGT Classification code 10024324 Term: Leukaemias
Conditions
Interventions
Trade Name: Ecalta
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ANIDULAFUNGIN
CAS Number: 166663-25-8
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS 2. Subject is at least 18 and not older than 65 years of age on the day of the first dosing. 3. Has no signs or symptoms of invasive fungal disease 4. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant 5. Has an ALAT, ALAT, alkaline phosphatase =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation 2. Known of positive HIV test or hepatitis B or C test in history. 3. History of QT time prolongation. 4. History of or current abuse of drugs, alcohol or solvents. 5. Inability to understand the nature of the trial and the procedures required. 6. Has not previously participated in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacokinetics of anidulafungin given once in every 2 days (q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS ;Primary end point(s): Geometric Mean Ratio (GMR) of the area under the concentration time curve (AUC) of anidulafungin: comparison between both treatment regimens after 600mg and after the last dose. ;Secondary Objective: To determine whether adequate exposure is attained by patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS when using a q48 hour or a q72 hour dosing regimen To determine whether infusion time can be advanced to 2 mg/min (both regimens) To determine the safety of anidulafungin in this patient population | — |
Countries
Netherlands
Outcome results
None listed