Clinical trial · Interventional
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
NCT02468284CI-TRIAL-00030070completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Degarelix
- interventionNames
- Drug: degarelix
Primary outcomes (8)
- measure
- Maximum plasma concentration observed (Cmax)
- timeFrame
- Day 0 - 196
- measure
- Time of Cmax after subcutaneous administration (Tmax)
- timeFrame
- Day 0 - 196
- measure
- Maximum plasma concentration observed (Cmax)
- timeFrame
- Day 0 - 28
- measure
- Maximum plasma concentration observed (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated * Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening * Has a screening serum testosterone level \>150 ng/dL * Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2 Exclusion Criteria: * Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit * Is currently treated with a 5-alpha reductase inhibitor * Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy * Is in need of neoadjuvant hormonal therapy * Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
References
Publications (0)
Data not yet available
No reference posted for this study.