Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000364976
Ethics application status
Approved
Date submitted
7/04/2011
Date registered
8/04/2011
Date last updated
8/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections
Scientific title
Pharmacokinetics and Safety of Solid Oral Posaconazole
(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)
Secondary ID [1] 259950 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Risk for Invasive Fungal Infection due to:
- Expected neutropenia (low white blood cell count) due to chemotherapy for Acute Myelogenous Leukaemia (AML) or Myelodysplastic Syndrome (MDS) 265576 0
High Risk for Invasive Fungal Infection due to:
- Hematopoietic stem cell transplant (HSCT) recipients undergoing treatment for graft-versus-host disease (GVHD) 265582 0
Condition category
Condition code
Infection 265721 265721 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Day 1: Two doses of 300mg SCH 056592 administered orally. The two doses of SCH 056592 will be given 12 hours apart.

Day 2 to 28: 300mg SCH 056592 administered orally once daily.
Intervention code [1] 264363 0
Treatment: Drugs
Comparator / control treatment
There is no control or comparator Treatment in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266483 0
To describe the drug absorption (Pharmacokinetic) profile of SCH 056592 in adults who have a weakened immune system because of a low white blood cell count (neutropenia) after chemotherapy or patients who have had a bone marrow or stem cell transplant (SCT) and are on immunosuppressant drugs to prevent rejection. Assessment will be through the collection of trough (low) blood samples.
Timepoint [1] 266483 0
Assessed at Day 1 (before the first dose of study drug), Day 2 (approx. 12 hours after the second dose of study drug given on Day 1), and then approx. 24 hours following the previous day?s dose of study drug at Day 3, Day 8 (+/-1 day), Day 14 (+/-1 day), Day 21 (+/-1 day), and Day 28 (+/-1 day).
Secondary outcome [1] 273869 0
Evaluate the safety of SCH 056592 in adults who have a weakened immune system because of a low white blood cell count (neutropenia) after chemotherapy or patients who have had a bone marrow or stem cell transplant (SCT) and are on immunosuppressant Assessments include vital signs, electrocardiographs (ECG), physical examinations, the analysis of blood tests and the monitoring of adverse events such as infections, laboratory abnormalities, cardiac events and changes in body weight. The study doctors will question subjects on any events that may have occurred between their study visits.drugs to prevent rejection.
Timepoint [1] 273869 0
Assessed at baseline, after 1, 2, 3, 8, 14, 21 and 28 days of treatment and then 7 days after study treatment has stopped.
Secondary outcome [2] 273881 0
Evaluate the gastrointestinal tolerability of SCH 056592 in adults who have a weakened immune system because of a low white blood cell count (neutropenia) after chemotherapy or patients who have had a bone marrow or stem cell transplant (SCT) and are on immunosuppressant drugs to prevent rejection. Assessments include the analysis of biochemistry blood tests and the monitoring of adverse events such as nausea, vomiting, diarrhoea, laboratory abnormalities and hepatic events. The study doctors will question subjects on any events that may have occurred between their study visits.
Timepoint [2] 273881 0
Assessed at baseline, after 1, 2, 3, 8, 14, 21 and 28 days of treatment and then 7 days after study treatment has stopped.
Secondary outcome [3] 273882 0
Assess the incidence of clinical failure during the exposure phase of the study. Assessments include monitoring for the clinical signs and symptoms of Invasive Fungal Infections, deaths, discontinuations, use of systemic anti-fungal treatments for empiric treatment of fungal infections for more than 4 days and a survival assessment. Study personnel will contact subjects via telephone to determine their survival status (alive or dead). If a subject has died, the date of death will be recorded.
Timepoint [3] 273882 0
Assessed at baseline, after 1, 2, 3, 8, 14, 21 and 28 days of treatment and then 7 days after study treatment has stopped.
Survival will be assessed at Day 65 (+/- 5 days).

Eligibility
Key inclusion criteria
1. Weighs more than 34 kg and of any race
2. Must be able to tolerate the administration of oral tablet medication.
3. Anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm3 to [0.5 x 109/L]) at Baseline and likely to last for at least 7 days due to: a. Standard intensive induction chemotherapy, for a new diagnosis of Acute Myelogenous Leukaemia (AML); b. Reinduction chemotherapy for Acute Myelogenous Leukaemia (AML) in first relapse; or c. myelosuppressive induction therapy for myelodysplastic syndromes (MDS)
4. Additional disease definition which may replace condition noted in Inclusion Criterion No. 3. Hematopoietic progenitor cell transplant subjects receiving immunosuppressive therapy for prevention or treatment of graft-versus-host disease
5. Must be free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the administration of study medication or study evaluations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Must not have a history of type I hypersensitivity or idiosyncratic reactions to azole agents.
2. Must not have moderate or severe liver dysfunction at Baseline.
3. Must not have an electrocardiogram (ECG) with a prolonged QTc interval (QTc greater than 500 msec).
4. Must not have taken posaconazole within 10 days prior to study enrolment.
5. Must not have taken prohibited medications prior to study entry.
6. Must not have received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrolment for reasons other than antifungal prophylaxis.
7. Must not have a known (including a possible, probable, or proven fungal infection per EORTC/MSG criteria) or suspected invasive or systemic fungal infection at Baseline.
8. Must not have gastric Graft-Versus-Host Disease (GVHD) Grade 2 or greater.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3344 0
New Zealand
State/province [1] 3344 0

Funding & Sponsors
Funding source category [1] 264835 0
Commercial sector/Industry
Name [1] 264835 0
Schering-Plough Pty limited
Country [1] 264835 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough Pty limited
Address
2015 Galloping Hill Road
Kenilworth, NJ 07033
Country
United States of America
Secondary sponsor category [1] 263939 0
None
Name [1] 263939 0
Address [1] 263939 0
Country [1] 263939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266800 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 266800 0
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, Qld, 4029
Ethics committee country [1] 266800 0
Australia
Date submitted for ethics approval [1] 266800 0
Approval date [1] 266800 0
07/09/2010
Ethics approval number [1] 266800 0
EC00172

Summary
Brief summary
Posaconazole (POS) is a systemic antifungal oral suspension approved for use as a treatment of refractory invasive fungal infection (rIFI), treatment of oro-pharyngeal thrush (candidiasis) and prevention (prophylaxis) of invasive fungal infection (IFI) in high-risk patients as a result of severe immuno-suppression. This includes those with neutropenia (low white blood cell count) after chemotherapy or patients who have had a bone marrow or stem cell transplant (HSCT) and are having treatment for graft-versus-host (GVHD) condition.

It is recommended that Posaconazole (POS) oral liquid suspension is taken several times a day and/or with a high fat meal or nutritional supplement to ensure that the medication is absorbed into the body. Such food intake is difficult to achieve in immuno-compromised, acutely ill patients, particularly patients with active Graft-Versus-Host Disease or patients with leukaemia undergoing acute chemotherapy.

A new solid oral formulation of Posaconazole (POS), SCH 056592, has been developed to optimize absorption in patients with limited food intake. It has been designed to release Posaconazole (POS) in the small intestine. This maximises its systemic absorption and overcomes the food-effect limitations of the oral suspension formulation.

The purpose of this study is to evaluate the amount of drug absorption and safety of SCH 056592 in a broad population of subjects who would benefit from antifungal prophylaxis and 2) compare these findings with results from other studies to support the selection of a dose for registration of the solid oral formulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32453 0
Address 32453 0
Country 32453 0
Phone 32453 0
Fax 32453 0
Email 32453 0
Contact person for public queries
Name 15700 0
Georgina Arnold
Address 15700 0
54-68 Ferndell Street
South Granville, NSW, 2142
Country 15700 0
Australia
Phone 15700 0
+61 2 9795 9309
Fax 15700 0
+61 2 9795 9955
Email 15700 0
[email protected]
Contact person for scientific queries
Name 6628 0
Georgina Arnold
Address 6628 0
54-68 Ferndell Street
South Granville, NSW, 2142
Country 6628 0
Australia
Phone 6628 0
+61 2 9795 9309
Fax 6628 0
+61 2 97959955
Email 6628 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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