Prostate CancerPhase 2NCT00117949

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated. 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: 82 participants
Where: 12 sitesUnited States
Study dates: Apr 2002to Jan 2004
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

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.)
Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
Is at least 18 years.
Has an ECOG score of 2.
Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
Has a PSA value of 2 ng/mL as measured by the central laboratory.
Has a life expectancy of at least 6 months.

Who cannot join

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:
Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
Requires hormonal therapy for neoadjuvant purposes.
Is recently (within the last 12 weeks preceding Visit 1) or presently treated 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.

Show all 13Show fewer

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 must be within normal limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Has received an investigational drug within the last 12 weeks preceding Visit 1.
Has previously participated in this study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Advanced Urology Medical Center
Anaheim, California, 92801
Urology Clinics of NorthTexas, PA
Dallas, Texas, 75231
Urology Associate PC'
Denver, Colorado, 80210
SW Florida Urological Associates
Fort Myers, Florida, 33907
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland, 20770
South Orange County Medical Research Center
Laguna Woods, California, 92653
Nevada Urology Associates
Reno, Nevada, 89511
Urology San Antonio Research
San Antonio, Texas, 78229
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710
Western Clinical Research
Torrance, California, 90505
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

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
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
DegarelixDrug
Also called FE200486
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
DegarelixDrug
Also called FE200486
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
DegarelixDrug
Also called FE200486
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Study groups in NCT00117949
Study group	Role	What they receive
Degarelix 40 mg	Experimental	Degarelix 40 mg (10 mg/mL) Receives: Drug: Degarelix
Degarelix 80 mg	Experimental	Degarelix 80 mg (20 mg/mL) Receives: Drug: Degarelix
Degarelix 120 mg	Experimental	Degarelix 120 mg (30 mg/mL) Receives: Drug: Degarelix
Degarelix 160 mg	Experimental	Degarelix 160 mg (40 mg/mL) Receives: Drug: Degarelix

What is being measured

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

Time to Meet Insufficient Testosterone Response
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Measured: 3 months
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
Measured: 28 days

Secondary outcomes (5)

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
Measured: 1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Measured: 3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
Measured: 3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
Measured: 3 months
Liver Function Tests
The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas 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 months

Timeline

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

Apr 2002Jan 2004

First posted11 Jul 2005 (estimated)
Study startApr 2002
Primary completionJan 2004
Study completionJan 2004

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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00117949
Sponsor's protocol ID: FE200486 CS06
Status last verified: May 2011
First submitted: 30 Jun 2005
Last updated: 23 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
ClinicalTrials.gov ID: NCT00117949
Acronym / sponsor ID: FE200486 CS06
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Androgen ablation therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2002
Primary completion: Jan 2004 (actual)
Study completion: Jan 2004 (actual)
First posted: 11 Jul 2005 (estimated)
Results: Posted 5 Jun 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Degarelix 40 mg	Experimental	Drug: DegarelixDegarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Experimental	Drug: DegarelixDegarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Experimental	Drug: DegarelixDegarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Experimental	Drug: DegarelixDegarelix 160 mg (40 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 (8 listed)

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.)
Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
Is at least 18 years.
Has an ECOG score of 2.
Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.

Key exclusion criteria (13 listed)

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:
Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
Requires hormonal therapy for neoadjuvant purposes.
Is recently (within the last 12 weeks preceding Visit 1) or presently treated 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.

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: FE200486One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.	Drug	Degarelix 40 mg
DegarelixAlso: FE200486One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.	Drug	Degarelix 80 mg
DegarelixAlso: FE200486One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.	Drug	Degarelix 120 mg
DegarelixAlso: FE200486One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.	Drug	Degarelix 160 mg

Primary outcome

Time to Meet Insufficient Testosterone Response
Time frame: 3 months
Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
Time frame: 28 days
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.

5 secondary outcomes

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
Time frame: 1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
Time frame: 3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
Time frame: 3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
Time frame: 3 months
Liver Function Tests
Time frame: 3 months

Results and safety

Results posted to the registry on 5 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 40 mg	10	0
Degarelix 80 mg	24	0
Degarelix 120 mg	24	0
Degarelix 160 mg	24	0

Primary outcome: Time to Meet Insufficient Testosterone Response

Time frame: 3 months. Median (Full Range). Unit: days

Measure	Degarelix 40 mg n = 10	Degarelix 80 mg n = 24	Degarelix 120 mg n = 24	Degarelix 160 mg n = 24
Value	14 (14 to 70)	77 (14 to 140)	98 (14 to 219)	28 (14 to 126)

Degarelix 40 mg vs Degarelix 80 mg vs Degarelix 120 mg vs Degarelix 160 mg: p <0.001, Log Rank
Degarelix 80 mg: Median days to insufficient T response: 84 (95% CI 35 to 112)
Degarelix 120 mg: Median days to insufficient T response: 98 (95% CI 70 to 126)

Population analysed: Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).

Primary outcome: Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

Time frame: 28 days. Number. Unit: participants

Measure	Degarelix 40 mg n = 10	Degarelix 80 mg n = 24	Degarelix 120 mg n = 24	Degarelix 160 mg n = 24
Value	1 (0.3 to 44.5)	17 (48.9 to 87.4)	19 (57.8 to 92.9)	13 (32.8 to 74.4)

Degarelix 40 mg vs Degarelix 80 mg vs Degarelix 120 mg vs Degarelix 160 mg: p = 0.181, Cochran-Armitage Trend Test.
Degarelix 40 mg: Percentage of participants: 10 (95% CI 0.3 to 44.5)
Degarelix 80 mg: Percentage of participants: 70.8 (95% CI 48.9 to 87.4)

5 secondary outcomes are 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 40 mg	0 of ?	6 of ?	Not reported
Degarelix 80 mg	1 of ?	18 of ?	Not reported
Degarelix 120 mg	1 of ?	20 of ?	Not reported
Degarelix 160 mg	0 of ?	13 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

12 sites in 1 country: see every site and its status.

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 at 12 sites in United States.

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 8 inclusion and 13 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: finished, as of the sponsor's last update on 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 5 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?

Time to Meet Insufficient Testosterone Response (time frame: 3 months). 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 NCT00117949.

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 23 May 2011.