Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

Ferring

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818623

FE200486 CS07

Details and patient eligibility

About

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

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.

Enrollment: 172 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained before any trial related procedures
• Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
• ECOG score to be equal to or above 2
• Testosterone level within age-specific normal range
• PSA value equal to or above 2 ng/ml
• Life expectancy of at least 6 months

Exclusion criteria

• Previous or current hormonal treatment of prostate cancer
• Recent or current treatment with any drugs modifying the testosterone level
• Candidate for curative treatment such as prostatectomy or radiotherapy
• History of severe asthma, anaphylactic reactions or Quincke's Oedema
• Hypersensitivity towards any component of FE200486
• Cancer disease within the last ten years except for prostate cancer and some skin cancers
• Signs of liver impairment shown as elevated serum ALT or serum bilirubin
• Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
• Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
• Mental incapacity or language barrier
• Having received an investigational product within the last 12 weeks preceding the trial
• Previous participation in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 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