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Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00818623
First received: January 7, 2009
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Time From Dosing Until Testosterone Levels >0.5 ng/mL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.


Secondary Outcome Measures:
  • Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days [ Time Frame: Two - six months ] [ Designated as safety issue: No ]
    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.

  • Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.

  • Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Time to 50% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.

  • Time to 90% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.

  • Evaluation of Liver Function Tests [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase 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.

  • Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.


Enrollment: 172
Study Start Date: November 2002
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 120 mg (20 mg/mL)
Degarelix 120 mg (20 mg/mL)
Drug: Degarelix
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 120 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)
Drug: Degarelix
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 160 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 200 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)
Drug: Degarelix
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 200 mg (60 mg/mL)
Degarelix 200 mg (60 mg/mL)
Drug: Degarelix
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (40 mg/mL)
Drug: Degarelix
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 240 mg (60 mg/mL)
Degarelix 240 mg (60 mg/mL)
Drug: Degarelix
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486
Experimental: Degarelix 320 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)
Drug: Degarelix
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
Other Name: FE200486

Detailed Description:

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained before any trial related procedures
  • Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions or Quincke's Oedema
  • Hypersensitivity towards any component of FE200486
  • Cancer disease within the last ten years except for prostate cancer and some skin cancers
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818623

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
KAS Glostrup
Glostrup, Denmark
KAS Herlev
Herlev, Denmark
Finland
Marian Sairaala
Helsinki, Finland
P-K Keskussairaala
Joensuu, Finland
Vuorikadun lääkäriasema
Kuopio, Finland
OYS
Oulu, Finland
Kirugikeskus
Seinäjoki, Finland
TAYS
Tampere, Finland
Hungary
Bajcsy-Zsilinszky Hospital, Urology
Budapest, Hungary
Jahn Ferenc Dél Pesti Hospital, Urology
Budapest, Hungary
Péterfy Hospital, Urology
Budapest, Hungary
Bács-Kiskun County Hospital, Urology
Kecskemét, Hungary
Hospital of Local Gov. Szeged, Urology
Szeged, Hungary
MÁV Hospital, Urology
Szolnok, Hungary
Norway
Sentralsykehuset i Rogland
Stavanger, Norway
Romania
CF2 Hospital - Bucharest, Urology
Bucharest, Romania
Dr. Th Burghele Hospital
Bucharest, Romania
Fundeni Hospital - Bucharest, Urology
Bucharest, Romania
County Hospital - Timisoara, Urology
Timisoara, Romania
Russian Federation
City Hospital #1, State Med Univ/Urology
Moscow, Russian Federation
Institute of Urology of MoH
Moscow, Russian Federation
Moscow City Hospital #60, Urology
Moscow, Russian Federation
City Hospital #15, Urology Department
St. Petersburg, Russian Federation
City Hospital #26, Urology Department
St. Petersburg, Russian Federation
Sweden
Sahlgrenska Universitetssjukehuset
Göteborg, Sweden
Helsingborgs Lasaret
Helsingborg, Sweden
Universitetssjukehuset, MAS
Malmö, Sweden
Akademiska Sjukhuset Uppsala
Uppsala, Sweden
University Hospital, Örebro
Örebro, Sweden
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00818623     History of Changes
Other Study ID Numbers: FE200486 CS07
Study First Received: January 7, 2009
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Finland: Finnish Medicines Agency
Finland: Ethics Committee
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Sweden: Medical Products Agency
Sweden: Swedish National Council on Medical Ethics
Romania: National Medicines Agency
Romania: Ministry of Public Health
Hungary: National Institute of Pharmacy
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014