Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Mycoses

Hematologic Neoplasms

Invasive Fungal Infections

Hematologic Diseases

Anti-Infective Agents

All Drugs and Chemicals

Isavuconazole

Clotrimazole

Miconazole

Antifungal Agents

Patients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing).

isavuconazonium sulfate - intravenous

isavuconazonium sulfate - oral

Senior Medical Director

The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.

A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.

Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.

Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.

Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.

Volume of distribution at steady state (Vss) will be model-derived.

Area under the concentration-time curve at steady state (AUCss) will be model-derived.

A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.

An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.

An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.

Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.

Basilea Pharmaceutica International Ltd

Astellas Pharma Global Development, Inc.

Symptoms and General Pathology

Rare Diseases

Leukemia

Communicable Diseases

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Pharmaceutical Solutions

Oliver Cornely, MD

Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.

Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.

Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients	NCT03241550	Hematological M...	isavuconazonium... isavuconazonium...	1 Year - 17 Years	Astellas Pharma Inc
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy	NCT00413439	Acute Myeloid L...	Isavuconazole	18 Years -	Basilea Pharmaceutica
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy	NCT00413439	Acute Myeloid L...	Isavuconazole	18 Years -	Basilea Pharmaceutica

Spots Global Cancer Trial Database for asp9766

Every month we try and update this database with for asp9766 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for asp9766

Every month we try and update this database with for asp9766 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for asp9766 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.