Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00117312Other idFE200486 CS06A

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: After 190 weeks \[7 patients left\] it was terminated for administrative reasons

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 37 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Oct 2002
Primary completion: Nov 2005
Completion: Nov 2005
First posted: 6 Jul 2005 (estimated)
Last update posted: 23 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

20022003200420052006

Ph 2
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
NCT00117312
Oct 2002 to Nov 2005
Terminated
Terminated

Registry summary

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

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Interventions

DegarelixDrug
DegarelixDrug
DegarelixDrug
DegarelixDrug

Arms4

Experimental
Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
Experimental
Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
Experimental
Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
Experimental
Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)

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 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 outcomeNumber· 3 years

Liver Function Tests

Group	Value (participants)
Degarelix 40 mg	0
Degarelix 80 mg	4
Degarelix 120 mg	5
Degarelix 160 mg	6

Primary outcomeNumber· 3 years

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Group	Value (participants)
Degarelix 40 mg	0
Degarelix 80 mg	1
Degarelix 120 mg	2
Degarelix 160 mg	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 40 mgDegarelix 40 mg (10 mg/mL)	–	0 / ?	6 / ?
Degarelix 80 mgDegarelix 80 mg (20 mg/mL)	–	5 / ?	19 / ?
Degarelix 120 mgDegarelix 120 mg (30 mg/mL)	–	7 / ?	21 / ?
Degarelix 160 mgDegarelix 160 mg (40 mg/mL)	–	2 / ?	16 / ?

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: Each patient must meet the following inclusion criteria before entry into the study: * Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days. Exclusion Criteria: Any patient meeting any of the following exclusion criteria will not be entered into the study: * Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures. * Requires hormonal therapy for neoadjuvant purposes. * Requires treatment with any other drug modifying the testosterone level or function. * Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1. * Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions. * Has hypersensitivity towards any component of the investigational product. * Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin. * Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator. * Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits). * Has a mental incapacity or language barrier precluding adequate understanding or co-operation.

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