A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 17
Updated:3/28/2019
Start Date:October 2, 2017
End Date:December 2019
Contact:Astellas Pharma Global Development
Email:Astellas.registration@astellas.com
Phone:800-888-7704

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

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.


Inclusion Criteria:

- Subject has sufficient venous access to permit administration of study drug (for the
IV cohorts), collection of pharmacokinetic samples and monitoring of safety
laboratories.

- Female subject must either:

- Be of non-childbearing potential: Clearly premenarchal or documented surgically
sterile

- Or, if of childbearing potential: Agree not to try to become pregnant during the
study and for 28 days after the final study drug administration; and have a
negative urine or serum pregnancy test at screening; and, if heterosexually
active, agree to consistently use 2 forms of highly effective birth control (at
least one of which must be a barrier method) starting at screening and throughout
the study and for 28 days after the final study drug administration.

- Female subject who is of childbearing potential must agree not to breastfeed starting
at screening and throughout the study and for 28 days after the final study drug
administration.

- Female subject who is of childbearing potential must not donate ova starting at
screening and throughout the study and for 28 days after the final study drug
administration.

- Male subject who is of childbearing potential and their female spouse/partner who is
of childbearing potential must be using highly effective contraception consisting of 2
forms of birth control (at least one of which must be a barrier method) starting at
screening and continue throughout the study, and for 90 days after the final study
drug administration.

- Male subject who is of childbearing potential must not donate sperm starting at
screening and throughout the study and, for 90 days after the final study drug
administration.

- Subject and subject's parent(s) or legal guardian agree that the subject will not
participate in another interventional study while on treatment.

- For oral cohorts: subject is able to swallow the oral capsule medication.

Exclusion Criteria:

- Subject has familial short QT syndrome, is receiving medications that are known to
shorten the QT interval, or has a clinically significant abnormal electrocardiogram
(ECG).

- Subject has evidence of hepatic dysfunction defined as:

- Total bilirubin ≥ 3 times the upper limit of normal (ULN)

- Alanine transaminase or aspartate transaminase ≥ 5 times the ULN

- Known cirrhosis or chronic hepatic failure

- Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as
ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St.
John's wort in the 5 days prior to the first administration of study drug.

- Subject has known history of allergy, hypersensitivity, or any serious reaction to any
of the azole class antifungals.

- Subject has any condition which makes the subject unsuitable for study participation.

- Subject is unlikely to survive 30 days.

- Subject has received investigational therapy, with the exception of oncology drug
trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.

- For oral cohorts: The subject has gastrointestinal disease or has had a procedure that
is expected to interfere with the oral absorption or tolerance of the study drug
(e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or
frequent vomiting).

- Subject previously dosed with isavuconazonium sulfate.
We found this trial at
21
sites
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Birmingham, Alabama 35233
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Cleveland, Ohio 44106
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, IN
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2401 Gillham Road
Kansas City, Missouri 64108
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Miami, Florida 33155
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Minneapolis, Minnesota 55404
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2220 Patterson Street
Nashville, Tennessee 37203
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San Francisco, California 94143
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750 East Adams Street
Syracuse, New York 13210
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