- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00630799
Efficacy and Safety Study of a New Leuprolide Acetate 17 mg Depot to Treat Prostate Cancer Patients
7. september 2010 oppdatert av: GP-Pharm
Efficacy and Safety of a New Leuprolide Acetate 17 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients
This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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New Port Richey, Florida, Forente stater, 34655
- Advanced Research Institute
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New Jersey
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Lawrenceville, New Jersey, Forente stater, 08648
- Lawrenceville Urology
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New York
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Poughkeepsie, New York, Forente stater, 12601
- Hudson Valley Urology
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27103
- Piedmont Medical Research
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Pennsylvania
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Bryn Mawr, Pennsylvania, Forente stater, 19010
- Center for Urologic Care
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South Carolina
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Myrtle Beach, South Carolina, Forente stater, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37209
- Urology Associates
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Texas
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San Antonio, Texas, Forente stater, 78229
- Urology San Antonio Research, PA
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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:
- Males 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy;
- life expectancy of at least 1 year;
- WHO/ECOG performance status of 0, 1, or 2;
- adequate renal function at screening as defined by serum creatinine <= 1.6 times the upper limit of normal (ULN) for the clinical laboratory;
- adequate and stable hepatic function as defined by bilirubin <= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) <= 2.5 times the ULN for the clinical laboratory at screening;
- ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
- signed written informed consent prior to inclusion in the study.
Exclusion Criteria:
- Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
- evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
- evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
- presence of any tumor in the immediate vicinity which could cause cord compression, in the opinion of the Investigator, taking into account medical history and clinical observations;
- excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
- testosterone levels <= 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site;
- previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline;
- previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (e.g. Lupron®, Zoladex®, etc.) (no wash-out allowed);
- previous treatment with AR-receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur®(no wash-out allowed);
- previous orchiectomy, adrenalectomy or hypophysectomy;
- previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate (TUR-P) within 2 weeks prior to or after baseline;
- previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks prior to or after baseline;
- any investigational drug within 5 half-lives of its physiological action or 3 months, whichever is longer, before baseline;
- administration of 5-α-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline;
- over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, DHEA) within the 3 months before baseline;
- hematological parameters (RBC, total and differential WBC count, platelet count, hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN) for the clinical laboratory at screening;
- co-existent malignancy, according to the Investigator's opinion;
- uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: >=160/100 mmHg) or symptomatic hypotension within 3 months before baseline;
- venous thrombosis within 6 months of baseline;
- uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH-RH analogues);
- history of drug and/or alcohol abuse within 6 months of baseline;
- serious concomitant illness(es) or disease(s) (e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol;
- patients on anticoagulative therapy including warfarin (Coumadin®) and heparin. Those patients on low dose low molecular weight heparin may be enrolled in the study;
- Abnormal coagulation studies (PT/PTT) at baseline.
- blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see exclusion 10);
- known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation;
history of the following prior to the study:
- immunization (within 4 weeks of baseline);
- flu shots (within 1 week of baseline or 1 week prior to and after study drug administration);
- anaphylaxis;
- skin disease which would interfere with injection site evaluation;
- dermatographism will be documented at screening and followed up while on treatment.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 1
leuprolide acetate administered by i.m. injection as two doses of 17 mg each during a period of 6 months (one dose every 3 months)
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17 mg i.m.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent of successful patients achieving chemical castration
Tidsramme: Days 28, 84, and 168
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Days 28, 84, and 168
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
WHO/ECOG performance status
Tidsramme: Days 14, 28, 56, 84, 112, and 168
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Days 14, 28, 56, 84, 112, and 168
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Serum LH concentration (mIU/mL)
Tidsramme: Days 2, 14, 28, 56, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 84, 86, 112, and 168
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Serum FSH concentration (mIU/mL)
Tidsramme: Days 2, 14, 28, 56, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 84, 86, 112, and 168
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Serum PSA concentration (ng/mL)
Tidsramme: Days 2, 14, 28, 56, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 84, 86, 112, and 168
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Frequency of bone pain
Tidsramme: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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plasma testosterone concentration (ng/mL) in PK population
Tidsramme: week 4 and week 12
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week 4 and week 12
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Occurrence of hot flushes
Tidsramme: Days 0, 2, 14, 28, 56, 84, 86, 112, and 168
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Days 0, 2, 14, 28, 56, 84, 86, 112, and 168
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Plasma leuprolide concentrations (pg/mL) in PK population
Tidsramme: Days 2, 14, 28, 56, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 84, 86, 112, and 168
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Frequency of urinary symptoms
Tidsramme: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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Frequency of urinary pain
Tidsramme: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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Days 2, 14, 28, 56, 54, 84, 86, 112, and 168
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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. mai 2008
Primær fullføring (Faktiske)
1. april 2009
Studiet fullført (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først innsendt
27. februar 2008
Først innsendt som oppfylte QC-kriteriene
27. februar 2008
Først lagt ut (Anslag)
7. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. september 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. september 2010
Sist bekreftet
1. september 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Genitale neoplasmer, hanner
- Prostata sykdommer
- Prostatiske neoplasmer
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Antineoplastiske midler, hormonelle
- Reproduktive kontrollmidler
- Fertilitetsmidler, kvinner
- Fruktbarhetsmidler
- Leuprolid
Andre studie-ID-numre
- GP/C/04/PRO
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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