Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115AM1)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00686543

Purpose

The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.

Condition	Intervention	Phase
Fungal Infection Acute Myelogenous Leukemia Neutropenia	Drug: Posaconazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients With Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Acute Myeloid Leukemia Fungal Infections Leukemia Molds

Drug Information available for: Posaconazole

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Mean POS Plasma Concentrations on Days 2, 3, and 8. [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8 ] [ Designated as safety issue: No ]
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ] [ Designated as safety issue: No ]
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8 ] [ Designated as safety issue: No ]
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8 ] [ Designated as safety issue: No ]
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ] [ Designated as safety issue: No ]
Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ] [ Designated as safety issue: No ]
Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.

Enrollment:	75
Study Start Date:	December 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15 POS 200 mg three times a day (TID) on Days 1-8 followed by continued randomized dosing regimen of POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.	Drug: Posaconazole Posaconazole will be used for prophylaxis Other Name: SCH 056592 - NOXAFIL®
Experimental: POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15 POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg twice a day (BID) on Days 9-15, administered with food or oral nutritional supplements.	Drug: Posaconazole Posaconazole will be used for prophylaxis Other Name: SCH 056592 - NOXAFIL®
Experimental: POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15 POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.	Drug: Posaconazole Posaconazole will be used for prophylaxis Other Name: SCH 056592 - NOXAFIL®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects >=18 years of age
High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.
High risk of invasive fungal infection (IFI) based on anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm^3 [0.5 x 10^9/L]).
Clinical laboratory safety tests within normal limits or clinically acceptable to the investigator or sponsor.
Free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the study evaluations.
Subjects must be willing to give written informed consent and able to adhere to dosing, study visit schedule, and mandatory procedures.

Exclusion Criteria:

Female subjects who are pregnant, intend to become pregnant, or are nursing.
Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days of Enrollment (ie, voriconazole, fluconazole [FLU], or itraconazole [ITZ]).
Subjects receiving posaconazole for prophylaxis against IFI 10 days prior to enrollment. (Subjects who are receiving either voriconazole or micafungin for prophylaxis against IFI should discontinue those therapies upon enrollment.)
Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.
Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.
Subjects who must take prohibited medications during the study.
Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
Subjects who are part of the staff personnel directly involved with this study.
Subjects who are a family member of the investigational study staff.
Prior enrollment in this study.
Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status >2 prior to induction chemotherapy for their underlying disease.
Subjects with proven or probable invasive or systemic fungal infection at Baseline.
Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00686543 History of Changes
Other Study ID Numbers:	P05115, EudraCT No. 2007-003148-31
Study First Received:	May 27, 2008
Results First Received:	April 15, 2010
Last Updated:	July 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Antifungal Agents
Anti-Infective Agents

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Mycoses
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders

Hematologic Diseases
Posaconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012