Status:
COMPLETED
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Fungal Infection
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 dosi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00686543
Start Date
December 1 2007
End Date
April 1 2009
Last Update
April 7 2017
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