Study to Find Maintenance Dose for Periodic Administration of ASP3550

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01261572
First received: December 1, 2010
Last updated: July 8, 2013
Last verified: July 2013

December 1, 2010
July 8, 2013
October 2010
April 2012   (final data collection date for primary outcome measure)
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time [ Time Frame: Baseline and for one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261572 on ClinicalTrials.gov Archive Site
  • Changes in serum level of testosterone over time [ Time Frame: Baseline and for one year ] [ Designated as safety issue: No ]
  • Changes in serum level of Luteinizing Hormone (LH) over time [ Time Frame: Baseline and for one year ] [ Designated as safety issue: No ]
  • Changes in serum level of Follicle Stimulating Hormone (FSH) over time [ Time Frame: Baseline and for one year ] [ Designated as safety issue: No ]
  • Changes in serum level of Prostate Specific Antigen (PSA) over time [ Time Frame: Baseline and for one year ] [ Designated as safety issue: No ]
  • Time to the recurrence of serum PSA [ Time Frame: For one year ] [ Designated as safety issue: No ]
  • Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Find Maintenance Dose for Periodic Administration of ASP3550
Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: ASP3350
periodic injection
  • Experimental: High dose group
    ASP3350 high dose
    Intervention: Drug: ASP3350
  • Experimental: Low dose group
    ASP3350 low dose
    Intervention: Drug: ASP3350
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01261572
3550-CL-0009
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP