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Study to Find Maintenance Dose for Periodic Administration of ASP3550

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01261572
First received: December 1, 2010
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
 Drug: ASP3350
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 155
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose group
ASP3350 high dose
 Drug: ASP3350
periodic injection
Experimental: Low dose group
ASP3350 low dose
 Drug: ASP3350
periodic injection

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261572

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shiku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01261572     History of Changes
Other Study ID Numbers: 3550-CL-0009
Study First Received: December 1, 2010
Last Updated: December 12, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP3550
Degarelix
Prostate cancer
Prostatic neoplasms

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013