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:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00117312

First received: June 30, 2005

Last updated: May 18, 2011

Last verified: May 2011

History of Changes

Results First Received: January 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Degarelix

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)

Participant Flow: Overall Study

	Degarelix 40 mg	Degarelix 80 mg	Degarelix 120 mg	Degarelix 160 mg
STARTED	10	24	24	24
Started FE200486 CS06A	1	11	16	9
COMPLETED	0	4 ^[1]	0	3
NOT COMPLETED	10	20	24	21
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

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Degarelix 40 mg	Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg	Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix 160 mg (40 mg/mL)
Total	Total of all reporting groups

Baseline Measures

Degarelix 40 mg

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Total

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Participants]

<=18 years

Between 18 and 65 years

>=65 years

Age
[Units: Years]
Mean (Standard Deviation)

72.0 (5.72)

77.5 (6.38)

75.9 (5.79)

74.7 (8.37)

75.6 (6.90)

Gender
[Units: Participants]

Female

Male

Race/Ethnicity, Customized
[Units: Participants]

Black

Caucasian

Other

Gleason score ^[1]
[Units: Participants]

Unknown

2-4

5-6

7-10

^[1]	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]
[Units: Participants]

Localized

Locally advanced

Metastatic

Not classifiable

^[1]	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]
[Units: Kilogram per square meter]
Mean (Standard Deviation)

26.7 (5.66)

26.6 (3.54)

27.2 (3.15)

26.6 (3.39)

26.8 (3.64)

^[1]	Body mass is a measure of body fat based on height and weight.

Time since prostate cancer diagnosis ^[1]
[Units: Days]
Mean (Standard Deviation)

851 (1077)

954 (1329)

1609 (1836)

1095 (1385)

1181 (1494)

^[1]	Mean number of days since the participants in each treatment were diagnosed with prostate cancer.

Weight
[Units: Kilogram]
Mean (Standard Deviation)

79.0 (11.7)

81.7 (11.5)

80.8 (12.8)

81.4 (14.4)

81.0 (12.6)

Outcome Measures

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1. Primary:

Liver Function Tests [ Time Frame: 3 years ]

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2. Primary:

Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 3 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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
e-mail: DK0-Disclosure@ferring.com

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

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