Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
This study has been terminated.
(After 190 weeks [7 patients left] it was terminated for administrative reasons)
Sponsor:
Ferring Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00117312
First received: June 30, 2005
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Degarelix |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Liver Function Tests [ Time Frame: 3 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 37 |
| Study Start Date: | October 2002 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
|
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
Other Name: FE200486
|
|
Experimental: Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
|
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
Other Name: FE200486
|
|
Experimental: Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
|
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
Other Name: FE200486
|
|
Experimental: Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
|
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
Other Name: FE200486
|
Detailed Description:
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117312
Locations
| United States, California | |
| Advanced Urology Medical Center | |
| Anaheim, California, United States, 92801 | |
| South Orange County Medical Research Center | |
| Laguna Woods,, California, United States, 92653 | |
| San Bernardino Urological Associates Medical Group | |
| San Bernardino, California, United States, 92404 | |
| Western Clinical Research | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Urology Associate PC` | |
| Denver, Colorado, United States, 80210 | |
| United States, Florida | |
| SW Florida Urological Associates | |
| Fort Myers, Florida, United States, 33907 | |
| Pinellas Urology, Inc. | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Maryland | |
| Drs. Werner, Murdock & Francis, PA | |
| Greenbelt, Maryland, United States, 20770 | |
| United States, Nevada | |
| Nevada Urology Associates | |
| Reno, Nevada, United States, 89511 | |
| United States, Oklahoma | |
| Urology Specialists of Oklahoma, Inc. | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Texas | |
| Urology Clinics of NorthTexas, PA | |
| Dallas, Texas, United States, 75231 | |
| Urology San Antonio Research | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Clinical Development Support, Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00117312 History of Changes |
| Other Study ID Numbers: | FE200486 CS06A |
| Study First Received: | June 30, 2005 |
| Results First Received: | January 22, 2009 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ferring Pharmaceuticals:
|
Prostate Cancer Androgen ablation therapy |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013