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:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: Fungal Infections Leukemia, Adult Acute Leukemia, Adult Chronic Molds

Drug Information available for: Posaconazole

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

POS concentrations obtained from plasma. The primary POS oral PK parameter to be determined is the mean plasma concentration for each patient. [ Time Frame: Blood samples for POS concentrations collected at days 2, 8, and 15. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events (AEs), including breakthrough IFI and premature discontinuation due to adverse events, clinical laboratory tests, and vital signs are to be assessed. Serious adverse events (SAEs) will be reported. [ Time Frame: AEs, discontinuations, clinical laboratory tests, and vital signs to be assessed up to study day 15. SAEs assessed up to 30 days after the last dose of study drug. ] [ Designated as safety issue: Yes ]

Estimated 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
Group 1: Experimental POS 200 mg TID with food or oral nutritional supplements for Days 9 to 15.	Drug: Posaconazole Posaconazole will be used for prophylaxis
Group 2: Experimental POS 400 mg BID with food or oral nutritional supplements for Days 9 to 15.	Drug: Posaconazole Posaconazole will be used for prophylaxis
Group 3: Experimental POS 400 mg TID with food or oral nutritional supplements for Days 9 to 15.	Drug: Posaconazole Posaconazole will be used for prophylaxis

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 IFI based on anticipated or documented prolonged neutropenia (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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05115, EudraCT No. 2007-003148-31
Study First Received:	May 27, 2008
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00686543 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Antifungal Agents
Anti-Infective Agents

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Neoplasms by Histologic Type
Hematologic Diseases
Agranulocytosis
Leukocyte Disorders
Leukemia, Myeloid
Infection
Leukemia, Myeloid, Acute

Pharmacologic Actions
Leukemia
Mycoses
Neutropenia
Antiparasitic Agents
Neoplasms
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Posaconazole
Leukopenia

ClinicalTrials.gov processed this record on February 08, 2010