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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818623
• Other study ID #: FE200486 CS07
• Status: Completed
• Phase: Phase 2
• Start date: November 2002
• Est. completion date: October 2004

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
• Degarelix
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	KAS Glostrup	Glostrup
Denmark	KAS Herlev	Herlev
Finland	Marian Sairaala	Helsinki
Finland	P-K Keskussairaala	Joensuu
Finland	Vuorikadun lääkäriasema	Kuopio
Finland	OYS	Oulu
Finland	Kirugikeskus	Seinäjoki
Finland	TAYS	Tampere
Hungary	Bajcsy-Zsilinszky Hospital, Urology	Budapest
Hungary	Jahn Ferenc Dél Pesti Hospital, Urology	Budapest
Hungary	Péterfy Hospital, Urology	Budapest
Hungary	Bács-Kiskun County Hospital, Urology	Kecskemét
Hungary	Hospital of Local Gov. Szeged, Urology	Szeged
Hungary	MÁV Hospital, Urology	Szolnok
Norway	Sentralsykehuset i Rogland	Stavanger
Romania	CF2 Hospital - Bucharest, Urology	Bucharest
Romania	Dr. Th Burghele Hospital	Bucharest
Romania	Fundeni Hospital - Bucharest, Urology	Bucharest
Romania	County Hospital - Timisoara, Urology	Timisoara
Russian Federation	City Hospital #1, State Med Univ/Urology	Moscow
Russian Federation	Institute of Urology of MoH	Moscow
Russian Federation	Moscow City Hospital #60, Urology	Moscow
Russian Federation	City Hospital #15, Urology Department	St. Petersburg
Russian Federation	City Hospital #26, Urology Department	St. Petersburg
Sweden	Sahlgrenska Universitetssjukehuset	Göteborg
Sweden	Helsingborgs Lasaret	Helsingborg
Sweden	Universitetssjukehuset, MAS	Malmö
Sweden	University Hospital, Örebro	Örebro
Sweden	Akademiska Sjukhuset Uppsala	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Denmark,  Finland,  Hungary,  Norway,  Romania,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Dosing Until Testosterone Levels >0.5 ng/mL	Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.	3 months
Secondary	Number of Participants With Testosterone Level =0.5 ng/mL for at Least 28 Days	The table shows the number of participants with testosterone level =0.5 ng/mL for at least 28 days.	Two - six months
Secondary	Number of Participants With Testosterone Level =0.5 ng/mL for at Least 84 Days	The table shows the number of participants with testosterone level =0.5 ng/mL for at least 84 days.	3 months
Secondary	Time to Testosterone Castration (Testosterone =0.5 ng/mL)	Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.	3 months
Secondary	Time to 50% Reduction in Prostate-specific Antigen Levels	The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.	3 months
Secondary	Time to 90% Reduction in Prostate-specific Antigen Levels	The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.	3 months
Secondary	Evaluation of Liver Function Tests	The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	3 months
Secondary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.	3 months