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Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

18. mai 2011 oppdatert av: Ferring Pharmaceuticals

An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

82

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Anaheim, California, Forente stater, 92801
        • Advanced Urology Medical Center
      • Laguna Woods,, California, Forente stater, 92653
        • South Orange County Medical Research Center
      • San Bernardino, California, Forente stater, 92404
        • San Bernardino Urological Associates Medical Group
      • Torrance, California, Forente stater, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, Forente stater, 80210
        • Urology Associate PC'
    • Florida
      • Fort Myers, Florida, Forente stater, 33907
        • SW Florida Urological Associates
      • St. Petersburg, Florida, Forente stater, 33710
        • Pinellas Urology, Inc.
    • Maryland
      • Greenbelt, Maryland, Forente stater, 20770
        • Drs. Werner, Murdock & Francis, PA
    • Nevada
      • Reno, Nevada, Forente stater, 89511
        • Nevada Urology Associates
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Urology Specialists of Oklahoma, Inc.
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Urology Clinics of NorthTexas, PA
      • San Antonio, Texas, Forente stater, 78229
        • Urology San Antonio Research

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:

Each patient must meet the following inclusion criteria before entry into the study:

  • Has given written consent before any study related activity is performed (A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.)
  • Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
  • Is at least 18 years.
  • Has an ECOG score of 2.
  • Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
  • Has a PSA value of 2 ng/mL as measured by the central laboratory.
  • Has a life expectancy of at least 6 months.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:

  • Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
  • Requires hormonal therapy for neoadjuvant purposes.
  • Is recently (within the last 12 weeks preceding Visit 1) or presently treated with any other drug modifying the testosterone level or function.
  • Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after Visit 1.
  • Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
  • Has hypersensitivity towards any component of the investigational product.
  • Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
  • Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator.
  • Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits).
  • Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
  • Has received an investigational drug within the last 12 weeks preceding Visit 1.
  • Has previously participated in this study.

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 40 mg
Degarelix 40 mg (10 mg/ml)
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 40 mg (10 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 80 mg (20 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 120 mg (30 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 160 mg (40 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Eksperimentell: Degarelix 80 mg
Degarelix 80 mg (20 mg/ml)
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 40 mg (10 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 80 mg (20 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 120 mg (30 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 160 mg (40 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Eksperimentell: Degarelix 120 mg
Degarelix 120 mg (30 mg/ml)
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 40 mg (10 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 80 mg (20 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 120 mg (30 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 160 mg (40 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Eksperimentell: Degarelix 160 mg
Degarelix 160 mg (40 mg/ml)
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 40 mg (10 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 80 mg (20 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 120 mg (30 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486
Legemiddel: Degarelix
En dose (2 x 2 ml) degarelix 160 mg (40 mg/ml), subkutan injeksjon.
Andre navn:
  • FE200486

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Meet Insufficient Testosterone Response
Tidsramme: 3 months
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
3 months
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
Tidsramme: 28 days
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Tidsramme: 1, 3, 7, 14, 21, 28, 42 days
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Tidsramme: 3 months
Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
Tidsramme: 3 months
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
Tidsramme: 3 months
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
3 months
Liver Function Tests
Tidsramme: 3 months
The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ferring Pharmaceuticals

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. april 2002

Primær fullføring (Faktiske)

1. januar 2004

Studiet fullført (Faktiske)

1. januar 2004

Datoer for studieregistrering

Først innsendt

30. juni 2005

Først innsendt som oppfylte QC-kriteriene

30. juni 2005

Først lagt ut (Anslag)

11. juli 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. mai 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2011

Sist bekreftet

1. mai 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FE200486 CS06

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