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

Ferring

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215657

FE200486 CS07A

Details and patient eligibility

About

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Full description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Enrollment: 131 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Males aged 18 or over
• Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
• Has completed Study FE200486 CS07
• Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 8 patient groups

Degarelix 120 mg (20 mg/mL)

Experimental group

Description:

Degarelix 120 mg (20 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 120 mg (40 mg/mL)

Experimental group

Description:

Degarelix 120 mg (40 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 160 mg (40 mg/mL)

Experimental group

Description:

Degarelix 160 mg (40 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 200 mg (40 mg/mL)

Experimental group

Description:

Degarelix 200 mg (40 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 200 mg (60 mg/mL)

Experimental group

Description:

Degarelix 200 mg (60 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 240 mg (40 mg/mL)

Experimental group

Description:

Degarelix 240 mg (40 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 240 mg (60 mg/mL)

Experimental group

Description:

Degarelix 240 mg (60 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 320 mg (60 mg/mL)

Experimental group

Description:

Degarelix 320 mg (60 mg/mL)

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix