Fungal InfectionsPhase 1NCT01716234

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

A Phase 1 study testing Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID and Posaconazole 18 mg/kg/day TID in people with Fungal Infections, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 3 months to 17 years
Conditions the study is for: Fungal Infections
What is being tested?: Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID and Posaconazole 18 mg/kg/day TID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: No sites listed yet
Study dates: 17 Apr 2008to 1 Apr 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 months to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

About this study

Official title: Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)

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.

Conditions: Fungal Infections
Being tested: Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID, Posaconazole 12 mg/kg/day TID
Medical subject headings: Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Posaconazole 12 mg/kg/day BIDDrug
Also called SCH 056592, MK-5592, Noxafil®
Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
Posaconazole 18 mg/kg/day BIDDrug
Also called SCH 056592, MK-5592, Noxafil®
Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
Posaconazole 18 mg/kg/day TIDDrug
Also called SCH 056592, MK-5592, Noxafil®
Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
Posaconazole 12 mg/kg/day TIDDrug
Also called SCH 056592, MK-5592, Noxafil®
Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)

Study groups in NCT01716234
Study group	Role	What they receive
POS 12 BID 2 to <7 Years	Experimental	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. Receives: Drug: Posaconazole 12 mg/kg/day BID
POS 12 BID 7 to <18 Years	Experimental	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. Receives: Drug: Posaconazole 12 mg/kg/day BID
POS 18 BID 2 to <7 Years	Experimental	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. Receives: Drug: Posaconazole 18 mg/kg/day BID
POS 18 BID 7 to <18 Years	Experimental	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. Receives: Drug: Posaconazole 18 mg/kg/day BID
POS 18 TID 2 to <7 Years	Experimental	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. Receives: Drug: Posaconazole 18 mg/kg/day TID
POS 18 TID 7 to <18 Years	Experimental	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. Receives: Drug: Posaconazole 18 mg/kg/day TID
POS 12 TID 3 months to <2 Years	Experimental	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. Receives: Drug: Posaconazole 12 mg/kg/day TID

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.
Measured: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.
Measured: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose

Secondary outcomes (2)

Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
Measured: Up to Day 58
Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
Measured: Up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 20081 Apr 2015

First posted29 Oct 2012 (estimated)
Study start17 Apr 2008
Primary completion1 Apr 2015
Study completion1 Apr 2015

Why it stopped: Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fungal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01716234
Sponsor's protocol ID: P03579
Other IDs: 2007-004645-15, MK-5592-032
Status last verified: Jul 2018
First submitted: 25 Oct 2012
Last updated: 27 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019.
PubMed 30913226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
ClinicalTrials.gov ID: NCT01716234
Acronym / sponsor ID: P03579
Conditions: Fungal Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.
Enrolment: 142 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Apr 2008 (actual)
Primary completion: 1 Apr 2015 (actual)
Study completion: 1 Apr 2015 (actual)
First posted: 29 Oct 2012 (estimated)
Results: Posted 15 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
POS 12 BID 2 to <7 Years	Experimental	Drug: Posaconazole 12 mg/kg/day BIDParticipants 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.
POS 12 BID 7 to <18 Years	Experimental	Drug: Posaconazole 12 mg/kg/day BIDParticipants 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.
POS 18 BID 2 to <7 Years	Experimental	Drug: Posaconazole 18 mg/kg/day BIDParticipants 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.
POS 18 BID 7 to <18 Years	Experimental	Drug: Posaconazole 18 mg/kg/day BIDParticipants 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.
POS 18 TID 2 to <7 Years	Experimental	Drug: Posaconazole 18 mg/kg/day TIDParticipants 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.
POS 18 TID 7 to <18 Years	Experimental	Drug: Posaconazole 18 mg/kg/day TIDParticipants 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.
POS 12 TID 3 months to <2 Years	Experimental	Drug: Posaconazole 12 mg/kg/day TIDParticipants 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.

Who may qualify

Ages: 3 months to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Posaconazole 12 mg/kg/day BIDAlso: SCH 056592, MK-5592, Noxafil®Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)	Drug	POS 12 BID 2 to <7 Years, POS 12 BID 7 to <18 Years
Posaconazole 18 mg/kg/day BIDAlso: SCH 056592, MK-5592, Noxafil®Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)	Drug	POS 18 BID 2 to <7 Years, POS 18 BID 7 to <18 Years
Posaconazole 18 mg/kg/day TIDAlso: SCH 056592, MK-5592, Noxafil®Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)	Drug	POS 18 TID 2 to <7 Years, POS 18 TID 7 to <18 Years
Posaconazole 12 mg/kg/day TIDAlso: SCH 056592, MK-5592, Noxafil®Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)	Drug	POS 12 TID 3 months to <2 Years

Primary outcome

Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
Time frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
Time frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.

2 secondary outcomes

Number of Participants With an Adverse Event
Time frame: Up to Day 58
Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
Time frame: Up to Day 28

Results and safety

Results posted to the registry on 15 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
POS 12 BID 2 to <7 Years	24	14
POS 12 BID 7 to <18 Years	22	12
POS 18 BID 2 to <7 Years	20	15
POS 18 BID 7 to <18 Years	28	16
POS 18 TID 2 to <7 Years	15	10
POS 18 TID 7 to <18 Years	32	18
POS 12 TID 3 Months to <2 Years	1	1

Primary outcome: Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)

Time frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups). Mean (Standard Deviation). Unit: ng/mL

Measure	POS 12 BID 2 to <7 Years n = 22	POS 12 BID 7 to <18 Years n = 19	POS 18 BID 2 to <7 Years n = 12	POS 18 BID 7 to <18 Years n = 12	POS 18 TID 2 to <7 Years n = 5	POS 18 TID 7 to <18 Years n = 10	POS 12 TID 3 Months to <2 Years n = 1
Value	122 (101)	107 (92.5)	112 (86.9)	113 (100)	68.4 (40.4)	57.9 (30.2)	68.5 (0)

Population analysed: The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.

Primary outcome: Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)

Time frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose. Mean (Standard Deviation). Unit: ng/mL

Measure	POS 12 BID 2 to <7 Years n = 16	POS 12 BID 7 to <18 Years n = 14	POS 18 BID 2 to <7 Years n = 12	POS 18 BID 7 to <18 Years n = 12	POS 18 TID 2 to <7 Years n = 5	POS 18 TID 7 to <18 Years n = 10	POS 12 TID 3 Months to <2 Years n = 1
Value	604 (779)	1050 (789)	485 (306)	1240 (1400)	620 (411)	1150 (750)	453 (0)

Population analysed: The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs: from Day 1 up to Day 39; SAEs: up to Day 58.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
POS 12 BID 2 to <7 Yrs	5 of 22 (22.7%)	21 of 22 (95.5%)	Not reported
POS 12 BID 7 to <18 Yrs	3 of 21 (14.3%)	20 of 21 (95.2%)	Not reported
POS 18 BID 2 to <7 Yrs	1 of 19 (5.3%)	16 of 19 (84.2%)	Not reported
POS 18 BID 7 to <18 Yrs	7 of 28 (25%)	26 of 28 (92.9%)	Not reported
POS 18 TID 2 to <7 Yrs	7 of 15 (46.7%)	13 of 15 (86.7%)	Not reported
POS 18 TID 7 to <18 Yrs	11 of 30 (36.7%)	28 of 30 (93.3%)	Not reported
POS 12 TID 3 Months to <2 Yrs	1 of 1 (100%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Only 1 participant was enrolled in the POS 12 TID 3 months to \<2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30913226Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID and Posaconazole 18 mg/kg/day TID in people with Fungal Infections, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose) (time frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01716234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.