A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)
8. juli 2015 opdateret af: Merck Sharp & Dohme LLC
A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Fase 1
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:
- Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy or for which standard therapy does not exist
- Patient has life expectancy of greater than 3 months
- Patient is able to swallow capsules
Exclusion Criteria:
- Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to taking study drug
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
- Patient has active CNS metastases and/or carcinomatous meningitis
- Patient has primary central nervous system tumor
- Patient has a history of drug or alcohol abuse
- Patient has Hepatitis B or C
- Patient is HIV positive
- Patient has active infection or has received intravenous antibiotics, antiviral or antifungal agents 2 weeks before taking study drug
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: A
Arm A: Drug/Placebo
|
A 2-part, crossover study.
Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2).
Part 2: All patients will receive 400 mg vorinostat capsules once daily.
Treatment will continue until disease progression or intolerable toxicity.
Andre navne:
A 2-part, crossover study.
Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
|
|
Eksperimentel: B
Arm B: Placebo/Drug
|
A 2-part, crossover study.
Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2).
Part 2: All patients will receive 400 mg vorinostat capsules once daily.
Treatment will continue until disease progression or intolerable toxicity.
Andre navne:
A 2-part, crossover study.
Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in QTcF at 0.5 Hours
Tidsramme: Baseline and 0.5 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 0.5 hours
|
|
Change From Baseline in QTcF at 1 Hour
Tidsramme: Baseline and 1 hour
|
Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 1 hour
|
|
Change From Baseline in QTcF at 2 Hours
Tidsramme: Baseline and 2 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 2 hours
|
|
Change From Baseline in QTcF at 3 Hours
Tidsramme: Baseline and 3 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 3 hours
|
|
Change From Baseline in QTcF at 4 Hours
Tidsramme: Baseline and 4 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.
|
Baseline and 4 hours
|
|
Change From Baseline in QTcF at 8 Hours
Tidsramme: Baseline and 8 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 8 hours
|
|
Change From Baseline in QTcF at 12 Hours
Tidsramme: Baseline and 12 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 12 hours
|
|
Change From Baseline in QTcF at 24 Hours
Tidsramme: Baseline and 24 hours
|
The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements.
The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.
|
Baseline and 24 hours
|
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. juli 2007
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
29. februar 2008
Først indsendt, der opfyldte QC-kriterier
29. februar 2008
Først opslået (Skøn)
11. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0683-070
- MK0683-070
- 2008_515
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