Prostate CancerPhase 2NCT00117312
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 at 12 sites in United States.
Trial summary
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. 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
- 37 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2002to Nov 2005
- 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.
- Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.
Who cannot join
- 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- Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA)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.
Show all 11Show 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 and bilirubin must be within normal limits).
- Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Trial locations and contacts
12 sites in 1 country.
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
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
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.
Read the detailed description
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
- 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 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.
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 participants 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.
- First posted6 Jul 2005 (estimated)
- Study startOct 2002
- Primary completionNov 2005
- Study completionNov 2005
Why it stopped: After 190 weeks \[7 patients left\] it was terminated for administrative reasons
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117312
- Sponsor's protocol ID
- FE200486 CS06A
- 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
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, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00117312
- Acronym / sponsor ID
- FE200486 CS06A
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Androgen ablation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 190 weeks \[7 patients left\] it was terminated for administrative reasons
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Jul 2005 (estimated)
- Results
- Posted 20 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
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 (3 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.
- Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.
Key exclusion criteria (11 listed)
- 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.
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
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 participants in each group with normal baseline and markedly abnormal value post-baseline.
Results and safety
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.
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
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 3 inclusion and 11 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 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 20 Mar 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?
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.