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Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1)

18. november 2013 opdateret af: Ferring Pharmaceuticals

Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada
        • Pacific Urologic Research
    • Ontario
      • Barrie, Ontario, Canada
        • Euroscope Inc
      • Brampton, Ontario, Canada
        • Bramalea Medical Centre
      • Kitchener, Ontario, Canada
        • Urology Associates/Urologic Medical Research
      • North Bay, Ontario, Canada
        • Office of Dr. Bernard Goldfarb
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Urology South Shore Research
  • Forenede Stater
    • Alabama
      • Homewood, Alabama, Forenede Stater
        • Urology Centers Of Alabama
    • California
      • Laguna Hills, California, Forenede Stater
        • South Orange County Urology Research
      • San Bernadino, California, Forenede Stater
        • San Bernadino Urological Association
    • Florida
      • Aventura, Florida, Forenede Stater
        • South Florida Medical Research
    • New York
      • Poughkeepsie, New York, Forenede Stater
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Concord, North Carolina, Forenede Stater
        • Carolina Clinical Trials
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater
        • Carolina Urologic Research Center
    • Texas
      • Dallas, Texas, Forenede Stater
        • Urology Clinic of North Texas
      • San Antonio, Texas, Forenede Stater
        • Urology San Antonio Research, PA

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

Han

Beskrivelse

Inclusion Criteria:

  • Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
  • Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan

  • Has a PSA level meeting one of these criteria:

    1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
    2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
    3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir
  • Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
  • Has an Eastern Cooperative Oncology Group score of ≤2
  • Has a life expectancy of at least one year

Exclusion Criteria:

  • Has had previous or is currently under hormonal management of prostate cancer
  • Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
  • Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  • Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
  • Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
  • Has a previous history or presence of another malignancy, other than prostate
  • Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
  • Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Degarelix - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Medicin: Degarelix
Eksperimentel: Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Medicin: Degarelix
Eksperimentel: Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Medicin: Degarelix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Tidsramme: Day 0-28 and at Day 112-140
Day 0-28 and at Day 112-140
Trough plasma levels (blood sample analysis)
Tidsramme: Day 28, 56, 84, 112, 140, 168 and 196
Actual levels prior to dosing
Day 28, 56, 84, 112, 140, 168 and 196

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with testosterone ≤0.5 ng/mL
Tidsramme: From baseline to Day 196
From baseline to Day 196
Serum levels of testosterone and PSA
Tidsramme: From baseline to Day 196
From baseline to Day 196
Percentage change in PSA levels
Tidsramme: From baseline to Day 196
From baseline to Day 196
Changes in patient-reported injection site pain (VAS scores over time)
Tidsramme: At 5 minutes and at 60 minutes after each injection
Will compare starting dose to maintenance doses
At 5 minutes and at 60 minutes after each injection
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Tidsramme: 60 minutes after each dosing injection
60 minutes after each dosing injection
Incidence and severity of investigator-evaluated injection site reactions
Tidsramme: From baseline to Day 196
From baseline to Day 196
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Tidsramme: From Day 28 onwards (up to Day 196)
From Day 28 onwards (up to Day 196)
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
Tidsramme: From Day 28 to Day 364
From Day 28 to Day 364
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Tidsramme: From baseline to Day 196
From baseline to Day 196
Clinically significant changes in laboratory values
Tidsramme: From baseline to Day 196
From baseline to Day 196
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
Tidsramme: From baseline to Day 196
From baseline to Day 196

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ferring Pharmaceuticals

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. januar 2012

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

22. november 2011

Først indsendt, der opfyldte QC-kriterier

12. december 2011

Først opslået (Skøn)

14. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 000008

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Degarelix

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Betingelser

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Narkotikainterventioner

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