Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

NCTNCT00245466Other idFE200486 CS02A

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The maintenance doses were too low to maintain testosterone suppression

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 88 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: Oct 2001
Primary completion: Mar 2006
Completion: Mar 2006
First posted: 28 Oct 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

2001200220032004200520062007

Ph 2
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
NCT00245466
Oct 2001 to Mar 2006
Terminated
Terminated

Registry summary

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

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Interventions

DegarelixDrug
DegarelixDrug
DegarelixDrug

Arms3

Experimental
Degarelix 80/80 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Experimental
Degarelix 40/40 + 40
In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
Experimental
Degarelix 80 + 20
In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

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.
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.

Secondary outcomes(1)

Serum Levels of Testosterone After 1, 2, and 3 Years
Time frame · 3 years

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

Group	Value (participants)
Degarelix 80/80 + 40	18
Degarelix 40/40 + 40	16
Degarelix 80 + 20	16

Primary outcomeNumber· 3 years

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Group	Value (participants)
Degarelix 80/80 + 40	1
Degarelix 40/40 + 40	0
Degarelix 80 + 20	2

Secondary and other outcome results(1)

Secondary outcomeMedian· 3 years

Serum Levels of Testosterone After 1, 2, and 3 Years

Group	Value (nanogram per milliliter)
Degarelix 80/80 + 40	0.120
Degarelix 40/40 + 40	0.086
Degarelix 80 + 20	0.170

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 80/80 + 40In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.	–	10 / ?	42 / ?
Degarelix 40/40 + 40In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.	–	14 / ?	40 / ?
Degarelix 80 + 20In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.	–	10 / ?	35 / ?

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: * Has completed study treatment in study FE200486 CS02. * Has completed visit 16 in study FE200486 CS02. * Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

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