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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00818623 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS07
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
172 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
7 countries

Denmark, Finland, Hungary, Norway, Romania, Russia, Sweden

Start
Nov 2002
Primary completion
Oct 2004
Completion
Oct 2004
First posted
8 Jan 2009 (estimated)
Last update posted
30 Nov 2023
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200320042005
  1. Ph 2

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

    NCT00818623

    Nov 2002 to Oct 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug

Arms8

  • Experimental

    Degarelix 120 mg (20 mg/mL)

    Degarelix 120 mg (20 mg/mL)

  • Experimental

    Degarelix 120 mg (40 mg/mL)

    Degarelix 120 mg (40 mg/mL)

  • Experimental

    Degarelix 160 mg (40 mg/mL)

    Degarelix 160 mg (40 mg/mL)

  • Experimental

    Degarelix 200 mg (40 mg/mL)

    Degarelix 200 mg (40 mg/mL)

  • Experimental

    Degarelix 200 mg (60 mg/mL)

    Degarelix 200 mg (60 mg/mL)

  • Experimental

    Degarelix 240 mg (40 mg/mL)

    Degarelix 240 mg (40 mg/mL)

  • Experimental

    Degarelix 240 mg (60 mg/mL)

    Degarelix 240 mg (60 mg/mL)

  • Experimental

    Degarelix 320 mg (60 mg/mL)

    Degarelix 320 mg (60 mg/mL)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time From Dosing Until Testosterone Levels >0.5 ng/mL

    Time frame · 3 months

    Registry description

    Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value \>0.5 ng/mL at Day 28 onwards.

Secondary outcomes(7)

  1. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days

    Time frame · Two - six months

    Registry description

    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.

  2. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days

    Time frame · 3 months

    Registry description

    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.

  3. Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)

    Time frame · 3 months

    Registry 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.

  4. Time to 50% Reduction in Prostate-specific Antigen Levels

    Time frame · 3 months

    Registry 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.

  5. Time to 90% Reduction in Prostate-specific Antigen Levels

    Time frame · 3 months

    Registry 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.

  6. Evaluation of Liver Function Tests

    Time frame · 3 months

    Registry 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.

  7. Participants With Markedly Abnormal Change in Vital Signs and Body Weight

    Time frame · 3 months

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 3 months

Time From Dosing Until Testosterone Levels >0.5 ng/mL

GroupValue (days)
Degarelix 120mg (20mg/mL)84
Degarelix 120mg (40mg/mL)63
Degarelix 160mg (40mg/mL)70
Degarelix 200mg (40mg/mL)140
Degarelix 200mg (60mg/mL)84
Degarelix 240mg (40mg/mL)140
Degarelix 240mg (60mg/mL)87.5
Degarelix 320mg (60mg/mL)133
Secondary and other outcome results(7)
Secondary outcomeNumber· Two - six months

Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days

GroupValue (participants)
Degarelix 120mg (20mg/mL)21
Degarelix 120mg (40mg/mL)8
Degarelix 160mg (40mg/mL)6
Degarelix 200mg (40mg/mL)24
Degarelix 200mg (60mg/mL)18
Degarelix 240mg (40mg/mL)22
Degarelix 240mg (60mg/mL)15
Degarelix 320mg (60mg/mL)24
Secondary outcomeNumber· 3 months

Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days

GroupValue (participants)
Degarelix 120mg (20mg/mL)11
Degarelix 120mg (40mg/mL)4
Degarelix 160mg (40mg/mL)3
Degarelix 200mg (40mg/mL)20
Degarelix 200mg (60mg/mL)11
Degarelix 240mg (40mg/mL)18
Degarelix 240mg (60mg/mL)12
Degarelix 320mg (60mg/mL)19
Secondary outcomeMedian· 3 months

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)

GroupValue (days)
Degarelix 120mg (20mg/mL)1
Degarelix 120mg (40mg/mL)1
Degarelix 160mg (40mg/mL)1.5
Degarelix 200mg (40mg/mL)1.5
Degarelix 200mg (60mg/mL)2
Degarelix 240mg (40mg/mL)1.5
Degarelix 240mg (60mg/mL)2
Degarelix 320mg (60mg/mL)1
Secondary outcomeMedian· 3 months

Time to 50% Reduction in Prostate-specific Antigen Levels

GroupValue (days)
Degarelix 120mg (20mg/mL)14
Degarelix 120mg (40mg/mL)21
Degarelix 160mg (40mg/mL)14
Degarelix 200mg (40mg/mL)14
Degarelix 200mg (60mg/mL)14
Degarelix 240mg (40mg/mL)14
Degarelix 240mg (60mg/mL)14
Degarelix 320mg (60mg/mL)14
Secondary outcomeMedian· 3 months

Time to 90% Reduction in Prostate-specific Antigen Levels

GroupValue (days)
Degarelix 120mg (20mg/mL)31.5
Degarelix 120mg (40mg/mL)35
Degarelix 160mg (40mg/mL)42
Degarelix 200mg (40mg/mL)35
Degarelix 200mg (60mg/mL)28
Degarelix 240mg (40mg/mL)42
Degarelix 240mg (60mg/mL)35
Degarelix 320mg (60mg/mL)45.5
Secondary outcomeNumber· 3 months

Evaluation of Liver Function Tests

GroupValue (participants)
Degarelix 120mg (20mg/mL)9
Degarelix 120mg (40mg/mL)2
Degarelix 160mg (40mg/mL)3
Degarelix 200mg (40mg/mL)7
Degarelix 200mg (60mg/mL)8
Degarelix 240mg (40mg/mL)4
Degarelix 240mg (60mg/mL)6
Degarelix 320mg (60mg/mL)6
Secondary outcomeNumber· 3 months

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

GroupValue (participants)
Degarelix 120mg (20mg/mL)0
Degarelix 120mg (40mg/mL)0
Degarelix 160mg (40mg/mL)0
Degarelix 200mg (40mg/mL)0
Degarelix 200mg (60mg/mL)1
Degarelix 240mg (40mg/mL)0
Degarelix 240mg (60mg/mL)1
Degarelix 320mg (60mg/mL)0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 120mg (20mg/mL)Degarelix 120 mg (20 mg/mL)–2 / ?14 / ?
Degarelix 120mg (40mg/mL)Degarelix 120 mg (40 mg/mL)–2 / ?10 / ?
Degarelix 160mg (40mg/mL)Degarelix 160 mg (40 mg/mL)–1 / ?7 / ?
Degarelix 200mg (40mg/mL)Degarelix 200 mg (40 mg/mL)–2 / ?20 / ?
Degarelix 200mg (60mg/mL)Degarelix 200 mg (60 mg/mL)–1 / ?14 / ?
Degarelix 240mg (40mg/mL)Degarelix 240 mg (40 mg/mL)–4 / ?22 / ?
Degarelix 240mg (60mg/mL)Degarelix 240 mg (60 mg/mL)–3 / ?10 / ?
Degarelix 320mg (60mg/mL)Degarelix 320 mg (60 mg/mL)–4 / ?19 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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