Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1)
18. november 2013 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
76
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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
-
-
-
-
Alabama
-
Homewood, Alabama, Forente stater
- Urology Centers of Alabama
-
-
California
-
Laguna Hills, California, Forente stater
- South Orange County Urology Research
-
San Bernadino, California, Forente stater
- San Bernadino Urological Association
-
-
Florida
-
Aventura, Florida, Forente stater
- South Florida Medical Research
-
-
New York
-
Poughkeepsie, New York, Forente stater
- Premier Medical Group of the Hudson Valley
-
-
North Carolina
-
Concord, North Carolina, Forente stater
- Carolina Clinical Trials
-
-
South Carolina
-
Myrtle Beach, South Carolina, Forente stater
- Carolina Urologic Research Center
-
-
Texas
-
Dallas, Texas, Forente stater
- Urology Clinic of North Texas
-
San Antonio, Texas, Forente stater
- Urology San Antonio Research, PA
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
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:
- For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
- 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
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Degarelix - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
|
|
|
Eksperimentell: Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
|
|
|
Eksperimentell: Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2012
Primær fullføring (Faktiske)
1. november 2012
Studiet fullført (Faktiske)
1. november 2012
Datoer for studieregistrering
Først innsendt
22. november 2011
Først innsendt som oppfylte QC-kriteriene
12. desember 2011
Først lagt ut (Anslag)
14. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. desember 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. november 2013
Sist bekreftet
1. november 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 000008
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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