- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00686543
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
9. marts 2017 opdateret af: Merck Sharp & Dohme LLC
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
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
75
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Posaconazole will be used for prophylaxis
Andre navne:
|
Eksperimentel: 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.
|
Posaconazole will be used for prophylaxis
Andre navne:
|
Eksperimentel: 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.
|
Posaconazole will be used for prophylaxis
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean POS Plasma Concentrations on Days 2, 3, and 8.
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8
|
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.
|
Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8
|
Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
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.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
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.
|
Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
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.
|
Predose (0 hour) and 5 hours postdose on Days 3 and 8
|
Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15
Tidsramme: Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
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.
|
Predose (0 hour) and 5 hours postdose on Days 8 and 15
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2007
Primær færdiggørelse (Faktiske)
1. april 2009
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
27. maj 2008
Først indsendt, der opfyldte QC-kriterier
29. maj 2008
Først opslået (Skøn)
30. maj 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Hæmatologiske sygdomme
- Bakterielle infektioner og mykoser
- Agranulocytose
- Leukopeni
- Leukocytlidelser
- Leukæmi
- Infektioner
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Mykoser
- Neutropeni
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 enzymhæmmere
- Hormonantagonister
- Antifungale midler
- Steroidsyntesehæmmere
- Antiprotozoale midler
- Antiparasitære midler
- 14-alfa-demethylasehæmmere
- Trypanocidale midler
- Posaconazol
Andre undersøgelses-id-numre
- P05115
- EudraCT No. 2007-003148-31
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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