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

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Degarelix
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: No sites listed yet
Study dates: Mar 2003to Mar 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

About this study

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

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

Read the 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 (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Conditions: Prostate Cancer
Being tested: Degarelix
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DegarelixDrug
Also called FE200486
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DegarelixDrug
Also called FE200486
Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).

Study groups in NCT00215657
Study group	Role	What they receive
Degarelix 120 mg (20 mg/mL)	Experimental	Degarelix 120 mg (20 mg/mL) Receives: Drug: Degarelix
Degarelix 120 mg (40 mg/mL)	Experimental	Degarelix 120 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 160 mg (40 mg/mL)	Experimental	Degarelix 160 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 200 mg (40 mg/mL)	Experimental	Degarelix 200 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 200 mg (60 mg/mL)	Experimental	Degarelix 200 mg (60 mg/mL) Receives: Drug: Degarelix
Degarelix 240 mg (40 mg/mL)	Experimental	Degarelix 240 mg (40 mg/mL) Receives: Drug: Degarelix
Degarelix 240 mg (60 mg/mL)	Experimental	Degarelix 240 mg (60 mg/mL) Receives: Drug: Degarelix
Degarelix 320 mg (60 mg/mL)	Experimental	Degarelix 320 mg (60 mg/mL) Receives: Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver Function Tests
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.
Measured: 3 years
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Mar 2006

First posted22 Sep 2005 (estimated)
Study startMar 2003
Primary completionMar 2006
Study completionMar 2006

Why it stopped: The doses were not effective in maintaining testosterone suppression

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00215657
Sponsor's protocol ID: FE200486 CS07A
Status last verified: May 2011
First submitted: 20 Sep 2005
Last updated: 20 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT00215657
Acronym / sponsor ID: FE200486 CS07A
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The doses were not effective in maintaining testosterone suppression
Enrolment: 131 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2003
Primary completion: Mar 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 12 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Degarelix 120 mg (20 mg/mL)	Experimental	Drug: DegarelixDegarelix 120 mg (20 mg/mL)
Degarelix 120 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 120 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 160 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 200 mg (40 mg/mL)
Degarelix 200 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 200 mg (60 mg/mL)
Degarelix 240 mg (40 mg/mL)	Experimental	Drug: DegarelixDegarelix 240 mg (40 mg/mL)
Degarelix 240 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 240 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)	Experimental	Drug: DegarelixDegarelix 320 mg (60 mg/mL)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DegarelixAlso: FE200486Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 120 mg (20 mg/mL)
DegarelixAlso: FE200486Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 120 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 160 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 200 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 200 mg (60 mg/mL)
DegarelixAlso: FE200486Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 240 mg (40 mg/mL)
DegarelixAlso: FE200486Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 240 mg (60 mg/mL)
DegarelixAlso: FE200486Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).	Drug	Degarelix 320 mg (60 mg/mL)

Primary outcome

Liver Function Tests
Time frame: 3 years
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
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.

Results and safety

Results posted to the registry on 12 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Degarelix 120mg (20mg/mL)	26	4
Degarelix 120mg (40mg/mL)	12	1
Degarelix 160mg (40mg/mL)	13	2
Degarelix 200mg (40mg/mL)	24	6
Degarelix 200mg (60mg/mL)	27	4
Degarelix 240mg (40mg/mL)	24	4
Degarelix 240mg (60mg/mL)	27	4
Degarelix 320mg (60mg/mL)	27	11

Primary outcome: Liver Function Tests

Time frame: 3 years. Number. Unit: participants

Measure	Degarelix 120mg (20mg/mL) n = 25	Degarelix 120mg (40mg/mL) n = 12	Degarelix 160mg (40mg/mL) n = 12	Degarelix 200mg (40mg/mL) n = 24	Degarelix 200mg (60mg/mL) n = 24	Degarelix 240mg (40mg/mL) n = 24	Degarelix 240mg (60mg/mL) n = 24	Degarelix 320mg (60mg/mL) n = 27
Abnormal alanine aminotransferase (ALAT)	11	4	3	7	7	7	7	9
Abnormal aspartate aminotransferase	9	4	2	6	8	6	6	7
Abnormal bilirubin	4	2	0	2	0	2	0	1
ALAT >3x ULN	4	0	0	0	0	2	1	1
ALAT >3x ULN, bilirubin >2x ULN	1	0	0	0	0	1	0	0

Population analysed: The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A

Primary outcome: Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Time frame: 3 years. Number. Unit: participants

Measure	Degarelix 120mg (20mg/mL) n = 25	Degarelix 120mg (40mg/mL) n = 12	Degarelix 160mg (40mg/mL) n = 12	Degarelix 200mg (40mg/mL) n = 24	Degarelix 200mg (60mg/mL) n = 24	Degarelix 240mg (40mg/mL) n = 24	Degarelix 240mg (60mg/mL) n = 24	Degarelix 320mg (60mg/mL) n = 27
Diastolic blood pressure <=50 and decrease >=15	0	0	0	0	1	0	1	0
Diastolic blood pressure >=105 and increase >=15	2	0	1	1	2	1	1	2
Systolic blood pressure <=90 and decrease >=20	0	0	0	0	0	0	0	0
Systolic blood pressure >=180 and increase >=20	0	0	2	5	2	6	2	3
Heart rate <=50 and decrease >=15	1	1	2	0	2	1	1	1
Heart rate >=120 and increase >=15	0	0	0	0	0	0	0	1
Body weight decrease of >=7 percent	1	0	1	1	0	1	1	1
Body weight increase of >=7 percent	4	2	3	9	3	8	7	2

Population analysed: These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Degarelix 120mg (20mg/mL)	8 of ?	18 of ?	Not reported
Degarelix 120mg (40mg/mL)	4 of ?	10 of ?	Not reported
Degarelix 160mg (40mg/mL)	3 of ?	9 of ?	Not reported
Degarelix 200mg (40mg/mL)	7 of ?	24 of ?	Not reported
Degarelix 200mg (60mg/mL)	8 of ?	17 of ?	Not reported
Degarelix 240mg (40mg/mL)	5 of ?	22 of ?	Not reported
Degarelix 240mg (60mg/mL)	3 of ?	12 of ?	Not reported
Degarelix 320mg (60mg/mL)	9 of ?	19 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver Function Tests (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00215657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011.