search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet
  • KAS Glostrup
  • KAS Herlev
  • Marian Sairaala
  • P-K Keskussairaala
  • Vuorikadun lääkäriasema
  • OYS
  • Kirugikeskus
  • TAYS
  • Bajcsy-Zsilinszky Hospital, Urology
  • Jahn Ferenc Dél Pesti Hospital, Urology
  • Péterfy Hospital, Urology
  • Bács-Kiskun County Hospital, Urology
  • Hospital of Local Gov. Szeged, Urology
  • MÁV Hospital, Urology
  • Sentralsykehuset i Rogland
  • CF2 Hospital - Bucharest, Urology
  • Dr. Th Burghele Hospital
  • Fundeni Hospital - Bucharest, Urology
  • County Hospital - Timisoara, Urology
  • City Hospital #1, State Med Univ/Urology
  • Institute of Urology of MoH
  • Moscow City Hospital #60, Urology
  • City Hospital #15, Urology Department
  • City Hospital #26, Urology Department
  • Sahlgrenska Universitetssjukehuset
  • Helsingborgs Lasaret
  • Universitetssjukehuset, MAS
  • Akademiska Sjukhuset Uppsala
  • University Hospital, Örebro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 7, 2009
Last Updated
May 18, 2011
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00818623
Brief Title
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 120 mg (20 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 120 mg (20 mg/mL)
Arm Title
Degarelix 120 mg (40 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 120 mg (40 mg/mL)
Arm Title
Degarelix 160 mg (40 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 160 mg (40 mg/mL)
Arm Title
Degarelix 200 mg (40 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 200 mg (40 mg/mL)
Arm Title
Degarelix 200 mg (60 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 200 mg (60 mg/mL)
Arm Title
Degarelix 240 mg (40 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 240 mg (40 mg/mL)
Arm Title
Degarelix 240 mg (60 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 240 mg (60 mg/mL)
Arm Title
Degarelix 320 mg (60 mg/mL)
Arm Type
Experimental
Arm Description
Degarelix 320 mg (60 mg/mL)
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
Primary Outcome Measure Information:
Title
Time From Dosing Until Testosterone Levels >0.5 ng/mL
Description
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
Description
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
Time Frame
Two - six months
Title
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
Description
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
Time Frame
3 months
Title
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Description
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 Frame
3 months
Title
Time to 50% Reduction in Prostate-specific Antigen Levels
Description
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 Frame
3 months
Title
Time to 90% Reduction in Prostate-specific Antigen Levels
Description
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.
Time Frame
3 months
Title
Evaluation of Liver Function Tests
Description
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.
Time Frame
3 months
Title
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
KAS Glostrup
City
Glostrup
Country
Denmark
Facility Name
KAS Herlev
City
Herlev
Country
Denmark
Facility Name
Marian Sairaala
City
Helsinki
Country
Finland
Facility Name
P-K Keskussairaala
City
Joensuu
Country
Finland
Facility Name
Vuorikadun lääkäriasema
City
Kuopio
Country
Finland
Facility Name
OYS
City
Oulu
Country
Finland
Facility Name
Kirugikeskus
City
Seinäjoki
Country
Finland
Facility Name
TAYS
City
Tampere
Country
Finland
Facility Name
Bajcsy-Zsilinszky Hospital, Urology
City
Budapest
Country
Hungary
Facility Name
Jahn Ferenc Dél Pesti Hospital, Urology
City
Budapest
Country
Hungary
Facility Name
Péterfy Hospital, Urology
City
Budapest
Country
Hungary
Facility Name
Bács-Kiskun County Hospital, Urology
City
Kecskemét
Country
Hungary
Facility Name
Hospital of Local Gov. Szeged, Urology
City
Szeged
Country
Hungary
Facility Name
MÁV Hospital, Urology
City
Szolnok
Country
Hungary
Facility Name
Sentralsykehuset i Rogland
City
Stavanger
Country
Norway
Facility Name
CF2 Hospital - Bucharest, Urology
City
Bucharest
Country
Romania
Facility Name
Dr. Th Burghele Hospital
City
Bucharest
Country
Romania
Facility Name
Fundeni Hospital - Bucharest, Urology
City
Bucharest
Country
Romania
Facility Name
County Hospital - Timisoara, Urology
City
Timisoara
Country
Romania
Facility Name
City Hospital #1, State Med Univ/Urology
City
Moscow
Country
Russian Federation
Facility Name
Institute of Urology of MoH
City
Moscow
Country
Russian Federation
Facility Name
Moscow City Hospital #60, Urology
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #15, Urology Department
City
St. Petersburg
Country
Russian Federation
Facility Name
City Hospital #26, Urology Department
City
St. Petersburg
Country
Russian Federation
Facility Name
Sahlgrenska Universitetssjukehuset
City
Göteborg
Country
Sweden
Facility Name
Helsingborgs Lasaret
City
Helsingborg
Country
Sweden
Facility Name
Universitetssjukehuset, MAS
City
Malmö
Country
Sweden
Facility Name
Akademiska Sjukhuset Uppsala
City
Uppsala
Country
Sweden
Facility Name
University Hospital, Örebro
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs