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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

NCTNCT00215657 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS07A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
131 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Mar 2003
Primary completion
Mar 2006
Completion
Mar 2006
First posted
22 Sept 2005 (estimated)
Last update posted
20 May 2011 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20032004200520062007
  1. Ph 2

    Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

    NCT00215657

    Mar 2003 to Mar 2006

    Terminated

Registry summary

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

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

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 outcomes2

Outcomes the sponsor listed as primary.

  1. Liver Function Tests

    Time frame · 3 years

    Registry description

    The figures present 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.

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

    Time frame · 3 years

    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 patients 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 outcomeNumber· 3 years

Liver Function Tests

GroupValue (participants)
Degarelix 120mg (20mg/mL)11
Degarelix 120mg (40mg/mL)4
Degarelix 160mg (40mg/mL)3
Degarelix 200mg (40mg/mL)7
Degarelix 200mg (60mg/mL)7
Degarelix 240mg (40mg/mL)7
Degarelix 240mg (60mg/mL)7
Degarelix 320mg (60mg/mL)9
Primary outcomeNumber· 3 years

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)–8 / ?18 / ?
Degarelix 120mg (40mg/mL)Degarelix 120 mg (40 mg/mL)–4 / ?10 / ?
Degarelix 160mg (40mg/mL)Degarelix 160 mg (40 mg/mL)–3 / ?9 / ?
Degarelix 200mg (40mg/mL)Degarelix 200 mg (40 mg/mL)–7 / ?24 / ?
Degarelix 200mg (60mg/mL)Degarelix 200 mg (60 mg/mL)–8 / ?17 / ?
Degarelix 240mg (40mg/mL)Degarelix 240 mg (40 mg/mL)–5 / ?22 / ?
Degarelix 240mg (60mg/mL)Degarelix 240 mg (60 mg/mL)–3 / ?12 / ?
Degarelix 320mg (60mg/mL)Degarelix 320 mg (60 mg/mL)–9 / ?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: * Males aged 18 or over * Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) * Has completed Study FE200486 CS07 * Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

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