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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

NCTNCT00117949 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS06
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
82 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2002
Primary completion
Jan 2004
Completion
Jan 2004
First posted
11 Jul 2005 (estimated)
Last update posted
23 May 2011 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200320042005
  1. Ph 2

    Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

    NCT00117949

    Apr 2002 to Jan 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.

Interventions

  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug
  • DegarelixDrug

Arms4

  • Experimental

    Degarelix 40 mg

    Degarelix 40 mg (10 mg/mL)

  • Experimental

    Degarelix 80 mg

    Degarelix 80 mg (20 mg/mL)

  • Experimental

    Degarelix 120 mg

    Degarelix 120 mg (30 mg/mL)

  • Experimental

    Degarelix 160 mg

    Degarelix 160 mg (40 mg/mL)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to Meet Insufficient Testosterone Response

    Time frame · 3 months

    Registry description

    Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.

  2. Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

    Time frame · 28 days

    Registry description

    The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.

Secondary outcomes(5)

  1. Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

    Time frame · 1, 3, 7, 14, 21, 28, 42 days

    Registry description

    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. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.

  2. Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

    Time frame · 3 months

    Registry description

    Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone \>1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.

  3. Time to 50% Reduction in Prostate-specific Antigen Levels

    Time frame · 3 months

    Registry description

    The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.

  4. Time to 90% Reduction in Prostate-specific Antigen Levels

    Time frame · 3 months

    Registry description

    The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.

  5. Liver Function Tests

    Time frame · 3 months

    Registry description

    The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 3 months

Time to Meet Insufficient Testosterone Response

GroupValue (days)
Degarelix 40 mg14
Degarelix 80 mg77
Degarelix 120 mg98
Degarelix 160 mg28
Primary outcomeNumber· 28 days

Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days

GroupValue (participants)
Degarelix 40 mg1
Degarelix 80 mg17
Degarelix 120 mg19
Degarelix 160 mg13
Secondary and other outcome results(5)
Secondary outcomeNumber· 1, 3, 7, 14, 21, 28, 42 days

Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).

GroupValue (days)
Degarelix 40 mg1
Degarelix 80 mg3
Degarelix 120 mg11
Degarelix 160 mg6
Secondary outcomeNumber· 3 months

Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days

GroupValue (participants)
Degarelix 40 mg0
Degarelix 80 mg9
Degarelix 120 mg14
Degarelix 160 mg7
Secondary outcomeMedian· 3 months

Time to 50% Reduction in Prostate-specific Antigen Levels

GroupValue (days)
Degarelix 40 mg10.5
Degarelix 80 mg14
Degarelix 120 mg14
Degarelix 160 mg14
Secondary outcomeMedian· 3 months

Time to 90% Reduction in Prostate-specific Antigen Levels

GroupValue (days)
Degarelix 40 mg28
Degarelix 80 mg35
Degarelix 120 mg35
Degarelix 160 mg31.5
Secondary outcomeNumber· 3 months

Liver Function Tests

GroupValue (participants)
Degarelix 40 mg0
Degarelix 80 mg3
Degarelix 120 mg3
Degarelix 160 mg6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 40 mgDegarelix 40 mg (10 mg/mL)–0 / ?6 / ?
Degarelix 80 mgDegarelix 80 mg (20 mg/mL)–1 / ?18 / ?
Degarelix 120 mgDegarelix 120 mg (30 mg/mL)–1 / ?20 / ?
Degarelix 160 mgDegarelix 160 mg (40 mg/mL)–0 / ?13 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Each patient must meet the following inclusion criteria before entry into the study: * Has given written consent before any study related activity is performed (A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.) * Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented. * Is at least 18 years. * Has an ECOG score of 2. * Has a baseline testosterone level within the age specific normal range as measured by the central laboratory. * Has a PSA value of 2 ng/mL as measured by the central laboratory. * Has a life expectancy of at least 6 months. Exclusion Criteria: Any patient meeting one or more of the following exclusion criteria will not be entered into the study: * Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of \< 6 months duration and completed \> 6 months prior to Visit 1. * Requires hormonal therapy for neoadjuvant purposes. * Is recently (within the last 12 weeks preceding Visit 1) or presently treated with any other drug modifying the testosterone level or function. * Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after Visit 1. * Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions. * Has hypersensitivity towards any component of the investigational product. * Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin. * Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation, or which may affect the conclusion of the study, as judged by the investigator. * Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases must be within normal limits). * Has a mental incapacity or language barrier precluding adequate understanding or co-operation. * Has received an investigational drug within the last 12 weeks preceding Visit 1. * Has previously participated in this study.

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