Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix 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

To investigate the long-term safety and tolerability of repeated doses of degarelix to 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: No sites listed yet
Study dates: Oct 2001to 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

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

Who cannot join

None listed.

About this study

Official title: An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.

To investigate the long-term safety and tolerability of repeated doses of degarelix to 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 CS02; NCT00819247) and the extension study FE200486 CS02A.

Conditions: Prostate Cancer
Being tested: Degarelix
Keywords: Prostate Cancer, Androgen ablation therapy
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
Given as a subcutaneous injection once every 4 weeks.
DegarelixDrug
Also called FE200486
Given as a subcutaneous injection once every 4 weeks.
DegarelixDrug
Also called FE200486
Given as a subcutaneous injection once every 4 weeks.

Study groups in NCT00245466
Study group	Role	What they receive
Degarelix 80/80 + 40	Experimental	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. Receives: Drug: Degarelix
Degarelix 40/40 + 40	Experimental	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. Receives: Drug: Degarelix
Degarelix 80 + 20	Experimental	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. 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

Secondary outcomes (1)

Serum Levels of Testosterone After 1, 2, and 3 Years
Measured: 3 years

Timeline

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

Oct 2001Mar 2006

First posted28 Oct 2005 (estimated)
Study startOct 2001
Primary completionMar 2006
Study completionMar 2006

Why it stopped: The maintenance doses were too low to maintain 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: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00245466
Sponsor's protocol ID: FE200486 CS02A
Status last verified: May 2011
First submitted: 26 Oct 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

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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-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
ClinicalTrials.gov ID: NCT00245466
Acronym / sponsor ID: FE200486 CS02A
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Androgen ablation therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The maintenance doses were too low to maintain testosterone suppression
Enrolment: 88 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2001
Primary completion: Mar 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 28 Oct 2005 (estimated)
Results: Posted 11 Jun 2009

Clinical summary

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

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

Detailed description

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Degarelix 80/80 + 40	Experimental	Drug: DegarelixIn 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.
Degarelix 40/40 + 40	Experimental	Drug: DegarelixIn 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.
Degarelix 80 + 20	Experimental	Drug: DegarelixIn 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.

Who may qualify

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

Key inclusion criteria (3 listed)

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

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: FE200486Given as a subcutaneous injection once every 4 weeks.	Drug	Degarelix 80/80 + 40
DegarelixAlso: FE200486Given as a subcutaneous injection once every 4 weeks.	Drug	Degarelix 40/40 + 40
DegarelixAlso: FE200486Given as a subcutaneous injection once every 4 weeks.	Drug	Degarelix 80 + 20

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 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 80/80 + 40	43	7
Degarelix 40/40 + 40	46	2
Degarelix 80 + 20	40	3

Primary outcome: Liver Function Tests

Time frame: 3 years. Number. Unit: participants

Measure	Degarelix 80/80 + 40 n = 43	Degarelix 40/40 + 40 n = 46	Degarelix 80 + 20 n = 40
Abnormal alanine aminotransferase (ALAT)	18	16	16
Abnormal aspartate aminotransferase	23	22	17
Abnormal bilirubin	3	4	5
ALAT >3x ULN	2	2	1
ALAT >3x ULN, bilirubin >1.5x ULN	0	0	1

Population analysed: The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.

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

Time frame: 3 years. Number. Unit: participants

Measure	Degarelix 80/80 + 40 n = 43	Degarelix 40/40 + 40 n = 46	Degarelix 80 + 20 n = 40
Diastolic blood pressure <=50 and decrease >=15	1	0	2
Diastolic blood pressure >=105 and increase >=15	0	2	0
Systolic blood pressure <=90 and decrease >=20	0	0	0
Systolic blood pressure >=180 and increase >=20	8	7	1
Heart rate <=50 and decrease >=15	0	1	2
Heart rate >=120 and increase >=15	0	0	0
Body weight decrease of >=7 percent	5	4	5
Body weight increase of >=7 percent	17	14	15

Population analysed: These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Degarelix 80/80 + 40	10 of ?	42 of ?	Not reported
Degarelix 40/40 + 40	14 of ?	40 of ?	Not reported
Degarelix 80 + 20	10 of ?	35 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 recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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 3 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 11 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 NCT00245466.

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.