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Study to Find Maintenance Dose for Periodic Administration of ASP3550

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01261572
Collaborator
(none)
155
Enrollment
8
Locations
2
Arms
18.4
Actual Duration (Months)
19.4
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Study Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
Actual Study Start Date :
Oct 12, 2010
Actual Primary Completion Date :
Apr 24, 2012
Actual Study Completion Date :
Apr 24, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: High dose group

ASP3350 high dose

Drug: degarelix
periodic injection
Other Names:
  • ASP3550

    		•
    Experimental: Low dose group

    ASP3350 low dose

    Drug: degarelix
    periodic injection
    Other Names:
  • ASP3550

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time [Baseline and for one year]

    Secondary Outcome Measures

    1. Changes in serum level of testosterone over time [Baseline and for one year]

    2. Changes in serum level of Luteinizing Hormone (LH) over time [Baseline and for one year]

    3. Changes in serum level of Follicle Stimulating Hormone (FSH) over time [Baseline and for one year]

    4. Changes in serum level of Prostate Specific Antigen (PSA) over time [Baseline and for one year]

    5. Time to the recurrence of serum PSA [For one year]

    6. Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically proven prostate cancer (adenocarcinoma) of all stages

    • A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention

    • Serum testosterone level above 2.2 ng/mL

    • An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2

    • Serum PSA level above 2 ng/mL

    Exclusion Criteria:
    • Previous or present endocrine treatment for prostate cancer.

    However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months

    • Treated with a 5α-reductase inhibitor

    • A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months

    • Concurrent or a history of severe liver disease

    • Abnormal ECG such as long QTc

    • A patient receiving ASP3550 in past times

    • Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chubu Japan
    2 Chugoku Japan
    3 Hokkaido Japan
    4 Kansai Japan
    5 Kantou Japan
    6 Kyusyu Japan
    7 Shiku Japan
    8 Touhoku Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01261572
    Other Study ID Numbers:
    • 3550-CL-0009
    First Posted:
    Dec 16, 2010
    Last Update Posted:
    Jun 4, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Inc
    Prostatic neoplasms
    Degarelix
    ASP3550
    Prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 4, 2019