Phase 2
Completed N=180
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
Source: ClinicalTrials.gov NCT00818623 ↗Enrolled (actual)
180
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Time From Dosing Until Testosterone Levels >0.5 ng/mL — 84; 63; 70; 140 days — p=0.0000586
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Dosing Until Testosterone Levels >0.5 ng/mL |
84; 63; 70; 140; 84; 140 | 0.0000586 sig |
| SECONDARY Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days |
21; 8; 6; 24; 18; 22 | 0.0014 sig |
| SECONDARY Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days |
11; 4; 3; 20; 11; 18 | 0.0031 sig |
| SECONDARY Time to Testosterone Castration (Testosterone ≤0.5 ng/mL) |
1; 1; 1.5; 1.5; 2; 1.5 | 0.0866 |
| SECONDARY Time to 50% Reduction in Prostate-specific Antigen Levels |
14; 21; 14; 14; 14; 14 | 0.033 sig |
| SECONDARY Time to 90% Reduction in Prostate-specific Antigen Levels |
31.5; 35; 42; 35; 28; 42 | 0.131 |
| SECONDARY Evaluation of Liver Function Tests |
9; 2; 3; 7; 8; 4 | — |
| SECONDARY Participants With Markedly Abnormal Change in Vital Signs and Body Weight |
0; 0; 0; 0; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00818623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.