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

An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix; Drug: Degarelix

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Glostrup, Denmark
    • KAS Glostrup
  • Herlev, Denmark
    • KAS Herlev
• Finland
  • Helsinki, Finland
    • Marian Sairaala
  • Joensuu, Finland
    • P-K Keskussairaala
  • Kuopio, Finland
    • Vuorikadun lääkäriasema
  • Oulu, Finland
    • OYS
  • Seinäjoki, Finland
    • Kirugikeskus
  • Tampere, Finland
    • TAYS
• Hungary
  • Budapest, Hungary
    • Bajcsy-Zsilinszky Hospital, Urology
  • Budapest, Hungary
    • Jahn Ferenc Dél Pesti Hospital, Urology
  • Budapest, Hungary
    • Péterfy Hospital, Urology
  • Kecskemét, Hungary
    • Bács-Kiskun County Hospital, Urology
  • Szeged, Hungary
    • Hospital of Local Gov. Szeged, Urology
  • Szolnok, Hungary
    • MÁV Hospital, Urology
• Norway
  • Stavanger, Norway
    • Sentralsykehuset i Rogland
• Romania
  • Bucharest, Romania
    • CF2 Hospital - Bucharest, Urology
  • Bucharest, Romania
    • Dr. Th Burghele Hospital
  • Bucharest, Romania
    • Fundeni Hospital - Bucharest, Urology
  • Timisoara, Romania
    • County Hospital - Timisoara, Urology
• Russian Federation
  • Moscow, 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
  • St. Petersburg, Russian Federation
    • City Hospital #15, Urology Department
  • St. Petersburg, Russian Federation
    • City Hospital #26, Urology Department
• Sweden
  • Göteborg, Sweden
    • Sahlgrenska Universitetssjukehuset
  • Helsingborg, Sweden
    • Helsingborgs Lasaret
  • Malmö, Sweden
    • Universitetssjukehuset, MAS
  • Uppsala, Sweden
    • Akademiska Sjukhuset Uppsala
  • Örebro, Sweden
    • University Hospital, Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix 120 mg (20 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 120 mg (40 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 160 mg (40 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 200 mg (40 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 200 mg (60 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 240 mg (40 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 240 mg (60 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486
Experimental: Degarelix 320 mg (60 mg/mL)	Drug: Degarelix; Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486; Drug: Degarelix; Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection; Other Names: FE200486

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Dosing Until Testosterone Levels >0.5 ng/mL	Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days	The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.	Two - six months
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days	The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.	3 months
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)	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.	3 months
Time to 50% Reduction in Prostate-specific Antigen Levels	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.	3 months
Time to 90% Reduction in Prostate-specific Antigen Levels	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.	3 months
Evaluation of Liver Function Tests	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.	3 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight	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.	3 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: January 7, 2009
• First Submitted That Met QC Criteria: January 7, 2009
• First Posted (Estimated): January 8, 2009

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS07