A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Fungal Infections

Treatments: Drug: Posaconazole 12 mg/kg/day TID; Drug: Posaconazole 18 mg/kg/day BID; Drug: Posaconazole 12 mg/kg/day BID; Drug: Posaconazole 18 mg/kg/day TID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01716234

2007-004645-15 (EudraCT Number)

MK-5592-032 (Other Identifier)

P03579

Details and patient eligibility

About

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.

Enrollment: 142 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
• Participants of child-bearing potential must use a medically accepted method of

contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.

Exclusion criteria

• Proven invasive fungal infection (IFI) before study entry
• Severe nausea and/or vomiting at screening
• Received posaconazole within 10 days before screening
• Unable to receive study drug by mouth or via an intestinal (enteral) tube
• Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
• History of anaphylaxis attributed to the azole class of antifungal agents

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 7 patient groups

POS 12 BID 2 to <7 Years

Experimental group

Description:

Participants aged 2 to \<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 12 mg/kg/day BID

POS 12 BID 7 to <18 Years

Experimental group

Description:

Participants aged 7 to \<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 12 mg/kg/day BID

POS 18 BID 2 to <7 Years

Experimental group

Description:

Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 18 mg/kg/day BID

POS 18 BID 7 to <18 Years

Experimental group

Description:

Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 18 mg/kg/day BID

POS 18 TID 2 to <7 Years

Experimental group

Description:

Participants aged 2 to \<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 18 mg/kg/day TID

POS 18 TID 7 to <18 Years

Experimental group

Description:

Participants aged 7 to \<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 18 mg/kg/day TID

POS 12 TID 3 months to <2 Years

Experimental group

Description:

Participants aged 3 months to \<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.

Treatment:

Drug: Posaconazole 12 mg/kg/day TID