Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

172

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline

Completed

Started Nov 2002

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach

7 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

November 1, 2002

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed

4.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed

3 months until next milestone

Results Posted

Study results publicly available

March 31, 2009

Completed

Last Updated

November 30, 2023

Status Verified

May 1, 2011

Enrollment Period

1.9 years

First QC Date

January 7, 2009

Results QC Date

January 22, 2009

Last Update Submit

November 8, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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 Outcomes (7)

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
3 months
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
3 months
+2 more secondary outcomes

Study Arms (8)

Degarelix 120 mg (20 mg/mL)

EXPERIMENTAL

Degarelix 120 mg (20 mg/mL)

Drug: Degarelix

Degarelix 120 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 120 mg (40 mg/mL)

Drug: Degarelix

Degarelix 160 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 160 mg (40 mg/mL)

Drug: Degarelix

Degarelix 200 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 200 mg (40 mg/mL)

Drug: Degarelix

Degarelix 200 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 200 mg (60 mg/mL)

Drug: Degarelix

Degarelix 240 mg (40 mg/mL)

EXPERIMENTAL

Degarelix 240 mg (40 mg/mL)

Drug: Degarelix

Degarelix 240 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 240 mg (60 mg/mL)

Drug: Degarelix

Degarelix 320 mg (60 mg/mL)

EXPERIMENTAL

Degarelix 320 mg (60 mg/mL)

Drug: Degarelix

Interventions

DegarelixDRUG

Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection

Also known as: FE200486

Degarelix 120 mg (20 mg/mL)

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ferring Pharmaceuticalslead

Study Sites (30)

Rigshospitalet

Copenhagen, Denmark

Location

KAS Glostrup

Glostrup Municipality, Denmark

Location

KAS Herlev

Herlev, Denmark

Location

Marian Sairaala

Helsinki, Finland

Location

P-K Keskussairaala

Joensuu, Finland

Location

Vuorikadun lääkäriasema

Kuopio, Finland

Location

OYS

Oulu, Finland

Location

Kirugikeskus

Seinäjoki, Finland

Location

TAYS

Tampere, Finland

Location

Bajcsy-Zsilinszky Hospital, Urology

Budapest, Hungary

Location

Jahn Ferenc Dél Pesti Hospital, Urology

Budapest, Hungary

Location

Péterfy Hospital, Urology

Budapest, Hungary

Location

Bács-Kiskun County Hospital, Urology

Kecskemét, Hungary

Location

Hospital of Local Gov. Szeged, Urology

Szeged, Hungary

Location

MÁV Hospital, Urology

Szolnok, Hungary

Location

Sentralsykehuset i Rogland

Stavanger, Norway

Location

CF2 Hospital - Bucharest, Urology

Bucharest, Romania

Location

Dr. Th Burghele Hospital

Bucharest, Romania

Location

Fundeni Hospital - Bucharest, Urology

Bucharest, Romania

Location

County Hospital - Timisoara, Urology

Timișoara, Romania

Location

City Hospital #1, State Med Univ/Urology

Moscow, Russia

Location

Institute of Urology of MoH

Moscow, Russia

Location

Moscow City Hospital #60, Urology

Moscow, Russia

Location

City Hospital #15, Urology Department

Saint Petersburg, Russia

Location

City Hospital #26, Urology Department

Saint Petersburg, Russia

Location

Sahlgrenska Universitetssjukehuset

Gothenburg, Sweden

Location

Helsingborgs Lasaret

Helsingborg, Sweden

Location

Universitetssjukehuset, MAS

Malmo, Sweden

Location

University Hospital, Örebro

Örebro, Sweden

Location

Akademiska Sjukhuset Uppsala

Uppsala, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title: Clinical Development Support
Organization: Ferring Pharmaceuticals

Study Officials

Clinical Development Support
Ferring Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

November 1, 2002

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

November 30, 2023

Results First Posted

March 31, 2009

Record last verified: 2011-05

Locations

RO(4)RU(5)SE(5)FI(6)DK(3)HU(6)NO(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (8)

Degarelix 120 mg (20 mg/mL)

Degarelix 120 mg (40 mg/mL)

Degarelix 160 mg (40 mg/mL)

Degarelix 200 mg (40 mg/mL)

Degarelix 200 mg (60 mg/mL)

Degarelix 240 mg (40 mg/mL)

Degarelix 240 mg (60 mg/mL)

Degarelix 320 mg (60 mg/mL)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations