A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00967018
• Collaborator: (none)
• Enrollment: 77
• Locations: 62
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Degarelix	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Degarelix The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.

Drug: Degarelix

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [Up to 22.5 months]

   The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

2. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [Up to 22.5 months]

   This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Other Outcome Measures

1. Serum Levels of Prostate Specific Antigen (PSA)Over Time [from baseline to 72 weeks]

   PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)

2. Serum Levels of Testosterone Over Time [from baseline to week 72]

   Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

• Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Bruxelles		Belgium
2	St. Elisabethziekenhuis	Turnhout		Belgium
3	Hopital Jean Minjoz	Besancon		France
4	Institut Bergonié	Bordeaux Cedex		France
5	Centre Francois Baclesse	Caen		France
6	CHU Henri Mondor	Creteil		France
7	Centre Oscar Lambret	Lille		France
8	Centre Leon Berard	Lyon		France
9	Hopital de la Timone	Marseille, Cedex		France
10	CRLC Val d' Aurelle - Oncology Radiotherapy	Montpellier		France
11	Hôpital Saint Louis - Radiotherapy Departement	Paris		France
12	Hôpital Tenon	Paris		France
13	Clinique Francheville	Perigueux		France
14	CHU La Milétrie - Oncology Radiotherapy	Poitiers		France
15	Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau	Saint Herblain Cedex		France
16	Institut de Cancérologie de la Loire	Saint Priest en Jarez		France
17	Clinique Saint Brieuc	St Brieuc Cedex		France
18	Centre Paul Strauss	Strassbourg		France
19	Centre de radiologie Saint Louis	Toulon		France
20	Clinique du Parc	Toulouse		France
21	IGR	Villejuif		France
22	Azienda Ospedaliero Universitaria Ospedali riuniti	Ancona		Italy
23	Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna	Bologna		Italy
24	Clinica Urologica 1 Universita Firenze	Firenze		Italy
25	Fondazione IRCCS Istituto Nazionale Tumori	Milano		Italy
26	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena	Milano		Italy
27	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy
28	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo	Palermo		Italy
29	Clinica Urologica - Azienda Ospedaliera di Perugia	Perugia		Italy
30	Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma	Roma		Italy
31	S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy
32	Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette	Torino		Italy
33	Hospital Fernando da Fonseca	Amadora		Portugal
34	Hospitais Universidade Coimbra	Coimbra		Portugal
35	Centro Hospitalar Lisboa Norte, Hospital Santa Maria	Lisboa		Portugal
36	Hospital S.João	Porto		Portugal
37	Hospital Universitario Principe de Asturias	Alcalá de Henares-Madrid		Spain
38	Fundacion Hospital Alcorcón	Alcorcon		Spain
39	Fundación Puigvert	Barcelona		Spain
40	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
41	Hospital Universitari Vall d´Hebron	Barcelona		Spain
42	Hospital de Basurto	Bilbao		Spain
43	Hospital Clinico Universitario S. Carlos	Madrid		Spain
44	Hospital Doce de Octubre	Madrid		Spain
45	Hospital universitario Ramón y Cajal	Madrid		Spain
46	Hospital Universitario Puerta de Hierro	Majadahonda		Spain
47	Hospital Manacor	Manacor		Spain
48	Hospital Universitario Central de Asturias	Oviedo		Spain
49	Hospital Santiago de Compostela	Santiago de Compostela		Spain
50	Hospital Virgen Macarena	Sevilla		Spain
51	Fundación IVO	Valencia		Spain
52	Hospital Xeral de Vigo	Vigo		Spain
53	Investigational site	Göteborg		Sweden
54	SU/Sahlgrenska	Göteborg		Sweden
55	Helsingborgs Lasarett	Helsingborg		Sweden
56	Universitetssjukhuset MAS	Malmö		Sweden
57	Södertälje Sjukhus	Södertälje		Sweden
58	Uppsala/Akademiska sjukhuset	Uppsala		Sweden
59	Ankara University Faculty of Medicine - Sıhhıye	Ankara		Turkey
60	Cerrahpasa Faculty of Medicine - Kocamustafapasa	Istanbul		Turkey
61	Istanbul University Faculty of Medicine - ÇAPA	Istanbul		Turkey
62	Marmara University Faculty of Medicine - Altunizade	Istanbul		Turkey

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00967018
• Other Study ID Numbers: FE200486 CS34; EudraCT No: 2008-006827-29
• First Posted: Aug 27, 2009
• Last Update Posted: Jan 3, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Ferring Pharmaceuticals: Safety parameters; ECG, blood and urine samples; general health state
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details	The patients were recruited from 16 sites in Belgium, France, Italy, Spain, Sweden and Turkey. The study was conducted between 31 August 2009 (FPFV) and 29 November 2011 (LPLV).

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Period Title: Overall Study
STARTED	77
COMPLETED	56
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Overall Participants	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.9 (7.59)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	77 100%
Region of Enrollment (participants) [Number]
France	2 2.6%
Spain	11 14.3%
Belgium	2 2.6%
Turkey	14 18.2%
Italy	35 45.5%
Sweden	13 16.9%
Body Mass Index (BMI) (kilogram per square meter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter]	27.2 (4.2)
Gleason Score (Number) [Number]
Gleason Score 2-4	1 1.3%
Gleason Score 5-6	18 23.4%
Gleason Score 7-10	58 75.3%
Stage of Prostate Cancer (Number) [Number]
Localized	36 46.8%
Locally Advanced	19 24.7%
Metastatic	15 19.5%
Not Classifiable	7 9.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description	The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame	Up to 22.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Measure Participants	77
B-Haematocrit (Ratio) <=0.37	24 31.2%
B-Haemoglobin (g/L) <=115	6 7.8%
B-White blood cell count (10^9/L) <=2.8	2 2.6%
B-White blood cell count (10^9/L) >=16.0	1 1.3%
B-Red blood cell count (10^12/L) <=3.5	3 3.9%
B-Platelet count (10^9/L) <=75	1 1.3%
S-Aspartate aminotransferase (IU/L) >3xULN	1 1.3%
S-Potassium (mmol/L) >=5.8	1 1.3%
S-Urea nitrogen (mmol/L) >=10.7	5 6.5%

2. Primary Outcome

Title	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time Frame	Up to 22.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Measure Participants	77
Diastolic blood pressure <=50 and decrease >=15	1 1.3%
Diastolic blood pressure >=105 and increase >=15	1 1.3%
Systolic blood pressure <=90 and decrease >=20	1 1.3%
Systolic blood pressure >=180 and increase >=20	0 0%
Heart rate <=50 and decrease >=15	0 0%
Heart rate >=120 and increase >=15	1 1.3%
Body weight decrease of >=7 percent	0 0%
Body weight increase of >=7 percent	2 2.6%

3. Other Pre-specified Outcome

Title	Serum Levels of Prostate Specific Antigen (PSA)Over Time
Description	PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
Time Frame	from baseline to 72 weeks

Outcome Measure Data

Analysis Population Description

The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Measure Participants	77
Baseline (0 weeks)	1.4
Week 24	0.75
Week 36	0.6
Week 48	0.55
Week 72	1.9

4. Other Pre-specified Outcome

Title	Serum Levels of Testosterone Over Time
Description	Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Time Frame	from baseline to week 72

Outcome Measure Data

Analysis Population Description

The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)

Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Measure Participants	77
Baseline (Week 0)	0.05
Week 24	0.05
Week 36	0.05
Week 48	0.08
Week 72	0.12

Adverse Events

Time Frame	Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
Adverse Event Reporting Description	Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Arm/Group Title	Degarelix
Arm/Group Description	The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
All Cause Mortality
	Degarelix
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Degarelix
	Affected / at Risk (%)	# Events
Total	5/77 (6.5%)
Blood and lymphatic system disorders
Thrombocytopenia	1/77 (1.3%)
Eye disorders
Vitreous haemorrhage	1/77 (1.3%)
General disorders
Chest pain	1/77 (1.3%)
Infections and infestations
Gastroenteritis	1/77 (1.3%)
Nervous system disorders
Convulsion	1/77 (1.3%)
Other (Not Including Serious) Adverse Events
	Degarelix
	Affected / at Risk (%)	# Events
Total	30/77 (39%)
Gastrointestinal disorders
Haematochezia	2/77 (2.6%)
Rectal tenesmus	2/77 (2.6%)
General disorders
Injection site inflammation	7/77 (9.1%)
Chills	4/77 (5.2%)
Injection site pain	4/77 (5.2%)
Chest pain	2/77 (2.6%)
Infections and infestations
Influenza	6/77 (7.8%)
Gastroenteritis	2/77 (2.6%)
Viral upper respiratory tract	2/77 (2.6%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	4/77 (5.2%)
Back pain	2/77 (2.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	2/77 (2.6%)
Nervous system disorders
Dizziness	2/77 (2.6%)
Syncope	2/77 (2.6%)
Vascular disorders
Hot flush	2/77 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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. Additional time may be required to allow Ferring to seek patent protection of the invention.