Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117312
Recruitment Status : Terminated (After 190 weeks [7 patients left] it was terminated for administrative reasons)
First Posted : July 6, 2005
Results First Posted : March 20, 2009
Last Update Posted : May 23, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Degarelix
Enrollment 37
Recruitment Details Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.
Pre-assignment Details  
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL)
Period Title: Overall Study
Started 10 24 24 24
Started FE200486 CS06A 1 11 16 9
Completed 0 4 [1] 0 3
Not Completed 10 20 24 21
Reason Not Completed
Testosterone >1.0 ng/mL             9             9             5             9
Testosterone 0.5 - 1.0 ng/mL             1             0             3             2
Prostate-specific antigen increase >=25%             0             1             5             3
Not specified             0             1             3             1
Patient choice             0             0             2             1
Adverse Event             0             2             0             0
Protocol Violation             0             1             3             0
PSA decrease <=50%             0             2             2             4
PSA increase >= 10ng/mL             0             1             1             0
Hepatic abnormality             0             1             0             1
Withdrawal by Subject             0             2             0             0
[1]
Defined as those patients ongoing when the extension study was terminated
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg Total
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL) Total of all reporting groups
Overall Number of Baseline Participants 10 24 24 24 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
1
   4.2%
2
   8.3%
4
  16.7%
8
   9.8%
>=65 years
9
  90.0%
23
  95.8%
22
  91.7%
20
  83.3%
74
  90.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
72.0  (5.72) 77.5  (6.38) 75.9  (5.79) 74.7  (8.37) 75.6  (6.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
24
 100.0%
24
 100.0%
24
 100.0%
82
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Black 2 1 2 1 6
Caucasian 5 23 15 20 63
Other 3 0 7 3 13
Gleason score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Unknown 0 1 0 0 1
2-4 1 1 1 0 3
5-6 3 14 12 13 42
7-10 6 8 11 11 36
[1]
Measure Description: The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Stage of prostate cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
Localized 5 11 12 10 38
Locally advanced 0 6 5 5 16
Metastatic 2 4 2 2 10
Not classifiable 3 3 5 7 18
[1]
Measure Description: Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
26.7  (5.66) 26.6  (3.54) 27.2  (3.15) 26.6  (3.39) 26.8  (3.64)
[1]
Measure Description: Body mass is a measure of body fat based on height and weight.
Time since prostate cancer diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
851  (1077) 954  (1329) 1609  (1836) 1095  (1385) 1181  (1494)
[1]
Measure Description: Mean number of days since the participants in each treatment were diagnosed with prostate cancer.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 10 participants 24 participants 24 participants 24 participants 82 participants
79.0  (11.7) 81.7  (11.5) 80.8  (12.8) 81.4  (14.4) 81.0  (12.6)
1.Primary Outcome
Title Liver Function Tests
Hide Description 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 0 4 5 6
Abnormal aspartate aminotransferase 1 13 18 9
Abnormal bilirubin 2 0 4 2
ALAT >3x ULN 0 1 0 0
ALAT >3x ULN, bilirubin >1.5x ULN 0 0 0 0
2.Primary Outcome
Title Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Hide Description 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description:
Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg (40 mg/mL)
Overall Number of Participants Analyzed 10 24 24 24
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 0 1 2 0
Diastolic blood pressure >=105 and increase >=15 0 0 0 0
Systolic blood pressure <=90 and decrease >=20 0 3 0 1
Systolic blood pressure >=180 and increase >=20 0 0 1 0
Heart rate <=50 and decrease >=15 0 1 2 3
Heart rate >=120 and increase >=15 0 0 0 0
Body weight decrease of >=7 percent 0 0 1 0
Body weight increase of >=7 percent 0 1 6 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Hide Arm/Group Description Degarelix 40 mg (10 mg/mL) Degarelix 80 mg (20 mg/mL) Degarelix 120 mg (30 mg/mL) Degarelix 160 mg (40 mg/mL)
All-Cause Mortality
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      5      7      2    
Cardiac disorders         
Aortic valve incompetence  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Bradycardia  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Cardiac arrest  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Coronary artery disease  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders         
Diverticulum intestinal haemorrhagic  1  0/10 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
Inguinal hernia  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  2 0/24 (0.00%)  0
Small intestinal obstruction  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
General disorders         
Chest pain  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Infections and infestations         
Lobar pneumonia  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Injury, poisoning and procedural complications         
Hip fracture  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1
Femur fracture  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Subdural haematoma  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Investigations         
Blood potassium increased  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Lung adenocarcinoma  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Tonsil cancer  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders         
Carotid artery stenosis  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Cerebrovascular accident  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Presyncope  1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  0/10 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix 40 mg Degarelix 80 mg Degarelix 120 mg Degarelix 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6      19      21      16    
Blood and lymphatic system disorders         
Anaemia  1  0/10 (0.00%)  0 2/24 (8.33%)  2 5/24 (20.83%)  8 0/24 (0.00%)  0
Cardiac disorders         
Angina pectoris  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 0/24 (0.00%)  0
Eye disorders         
Diabetic retinopathy  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  0/10 (0.00%)  0 4/24 (16.67%)  4 2/24 (8.33%)  2 2/24 (8.33%)  3
Diarrhoea  1  0/10 (0.00%)  0 2/24 (8.33%)  2 4/24 (16.67%)  4 0/24 (0.00%)  0
Inguinal hernia  1  0/10 (0.00%)  0 3/24 (12.50%)  4 1/24 (4.17%)  1 0/24 (0.00%)  0
Dyspepsia  1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  2 1/24 (4.17%)  2
Haemorrhoids  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
General disorders         
Oedema peripheral  1  0/10 (0.00%)  0 1/24 (4.17%)  1 3/24 (12.50%)  4 0/24 (0.00%)  0
Fatigue  1  1/10 (10.00%)  1 3/24 (12.50%)  3 1/24 (4.17%)  1 3/24 (12.50%)  4
Injection site pruritus  1  0/10 (0.00%)  0 4/24 (16.67%)  4 2/24 (8.33%)  2 0/24 (0.00%)  0
Injection site pain  1  0/10 (0.00%)  0 3/24 (12.50%)  4 3/24 (12.50%)  5 1/24 (4.17%)  1
Asthenia  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 0/24 (0.00%)  0
Chest pain  1  0/10 (0.00%)  0 3/24 (12.50%)  7 0/24 (0.00%)  0 0/24 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  0/10 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  3 0/24 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  0/10 (0.00%)  0 3/24 (12.50%)  3 3/24 (12.50%)  4 3/24 (12.50%)  3
Urinary tract infection  1  0/10 (0.00%)  0 3/24 (12.50%)  8 1/24 (4.17%)  1 1/24 (4.17%)  2
Influenza  1  0/10 (0.00%)  0 2/24 (8.33%)  2 2/24 (8.33%)  2 0/24 (0.00%)  0
Pharyngitis  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications         
Procedural pain  1  0/10 (0.00%)  0 3/24 (12.50%)  4 0/24 (0.00%)  0 0/24 (0.00%)  0
Injury  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Fall  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Investigations         
Weight increased  1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  2 0/24 (0.00%)  0
Alanine aminotransferase increased  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Aspartate aminotransferase increased  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Breath sounds abnormal  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Metabolism and nutrition disorders         
Hypercholesterolaemia  1  0/10 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0
Hyperlipidaemia  1  0/10 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/10 (0.00%)  0 2/24 (8.33%)  3 1/24 (4.17%)  1 1/24 (4.17%)  1
Back pain  1  1/10 (10.00%)  1 1/24 (4.17%)  1 0/24 (0.00%)  0 1/24 (4.17%)  1
Osteoarthritis  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders         
Dizziness  1  1/10 (10.00%)  1 3/24 (12.50%)  4 3/24 (12.50%)  3 1/24 (4.17%)  1
Headache  1  1/10 (10.00%)  1 3/24 (12.50%)  3 3/24 (12.50%)  3 0/24 (0.00%)  0
Sciatica  1  0/10 (0.00%)  0 2/24 (8.33%)  3 0/24 (0.00%)  0 0/24 (0.00%)  0
Psychiatric disorders         
Libido decreased  1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  3 3/24 (12.50%)  4
Renal and urinary disorders         
Dysuria  1  0/10 (0.00%)  0 3/24 (12.50%)  5 1/24 (4.17%)  1 2/24 (8.33%)  2
Urinary retention  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 1/24 (4.17%)  1
Urine flow decreased  1  1/10 (10.00%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0
Reproductive system and breast disorders         
Gynaecomastia  1  0/10 (0.00%)  0 4/24 (16.67%)  4 1/24 (4.17%)  1 1/24 (4.17%)  1
Testicular atrophy  1  0/10 (0.00%)  0 2/24 (8.33%)  2 1/24 (4.17%)  1 1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/10 (0.00%)  0 2/24 (8.33%)  2 2/24 (8.33%)  2 1/24 (4.17%)  1
Dyspnoea  1  0/10 (0.00%)  0 2/24 (8.33%)  3 1/24 (4.17%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  0/10 (0.00%)  0 2/24 (8.33%)  4 0/24 (0.00%)  0 0/24 (0.00%)  0
Vascular disorders         
Hot flush  1  2/10 (20.00%)  2 14/24 (58.33%)  16 6/24 (25.00%)  8 5/24 (20.83%)  5
Hypertension  1  0/10 (0.00%)  0 0/24 (0.00%)  0 4/24 (16.67%)  4 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
Results Point of Contact
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117312     History of Changes
Other Study ID Numbers: FE200486 CS06A
First Submitted: June 30, 2005
First Posted: July 6, 2005
Results First Submitted: January 22, 2009
Results First Posted: March 20, 2009
Last Update Posted: May 23, 2011