Clinical trial NCT00818623: Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
Official title: An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 172
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Time From Dosing Until Testosterone Levels >0.5 ng/mL
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
timeFrame: Two - six months
measure: Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
timeFrame: 3 months
measure: Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
timeFrame: 3 months
measure: Time to 50% Reduction in Prostate-specific Antigen Levels
timeFrame: 3 months
measure: Time to 90% Reduction in Prostate-specific Antigen Levels
timeFrame: 3 months
measure: Evaluation of Liver Function Tests
timeFrame: 3 months
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Glostrup
country: Denmark
facility: KAS Glostrup
city: Herlev
country: Denmark
facility: KAS Herlev
city: Helsinki
country: Finland
facility: Marian Sairaala
city: Joensuu
country: Finland
facility: P-K Keskussairaala
city: Kuopio
country: Finland
facility: Vuorikadun lääkäriasema
city: Oulu
country: Finland
facility: OYS
city: Seinäjoki
country: Finland
facility: Kirugikeskus
city: Tampere
country: Finland
facility: TAYS
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital, Urology
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél Pesti Hospital, Urology
city: Budapest
country: Hungary
facility: Péterfy Hospital, Urology
city: Kecskemét
country: Hungary
facility: Bács-Kiskun County Hospital, Urology
city: Szeged
country: Hungary
facility: Hospital of Local Gov. Szeged, Urology
city: Szolnok
country: Hungary
facility: MÁV Hospital, Urology
city: Stavanger
country: Norway
facility: Sentralsykehuset i Rogland
city: Bucharest
country: Romania
facility: CF2 Hospital - Bucharest, Urology
city: Bucharest
country: Romania
facility: Dr. Th Burghele Hospital
city: Bucharest
country: Romania
facility: Fundeni Hospital - Bucharest, Urology
city: Timisoara
country: Romania
facility: County Hospital - Timisoara, Urology
city: Moscow
country: Russian Federation
facility: City Hospital #1, State Med Univ/Urology
city: Moscow
country: Russian Federation
facility: Institute of Urology of MoH
city: Moscow
country: Russian Federation
facility: Moscow City Hospital #60, Urology
city: St. Petersburg
country: Russian Federation
facility: City Hospital #15, Urology Department
city: St. Petersburg
country: Russian Federation
facility: City Hospital #26, Urology Department
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukehuset
city: Helsingborg
country: Sweden
facility: Helsingborgs Lasaret
city: Malmö
country: Sweden
facility: Universitetssjukehuset, MAS
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset Uppsala
city: Örebro
country: Sweden
facility: University Hospital, Örebro
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: