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Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

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Status and phase

Completed
Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Degarelix 240/80 mg

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01071915
FE200486 CS42

Details and patient eligibility

About

This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Enrollment

157 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has given written informed consent before any trial-related activity is performed.
  • Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
  • Is a male patient aged 18 years or older
  • Has a screening serum testosterone level >1.5 ng/mL
  • Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
  • Has a screening PSA value of ≥2 ng/mL
  • Has a life expectancy of at least 12 months

Exclusion criteria

  • Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
  • Is currently treated with a 5-α-reductase inhibitor
  • Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
  • Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
  • Has hypersensitivity towards any component of the investigational medicinal product
  • A marked baseline prolongation of QT/QTcF interval
  • A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
  • Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
  • Has a known or suspect hepatic, symptomatic biliary disease
  • Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
  • Has other clinically significant laboratory abnormalities
  • Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
  • Has a mental incapacity or language barriers precluding adequate understanding or co- operation
  • Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
  • Has previously participated in any degarelix trial

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

157 participants in 1 patient group

Degarelix 240/80 mg
Experimental group
Description:
The degarelix doses were administered into the abdominal wall every 28 days. 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 maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Treatment:
Drug: Degarelix 240/80 mg

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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