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

November 8, 2023 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time From Dosing Until Testosterone Levels >0.5 ng/mL
Time Frame: 3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
Time Frame: Two - six months
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
Time Frame: 3 months
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 Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE200486 CS07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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