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

Tracking Information

First Received Date ^ICMJE

December 1, 2010

Last Updated Date

December 12, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01261572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Find Maintenance Dose for Periodic Administration of ASP3550

Official Title ^ICMJE

Phase II Study of ASP3550 - A Maintenance-dose Finding Study for Periodic Dosage Regimen in Patients With Prostate Cancer -

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Drug: ASP3350

periodic injection

Study Arm (s)

Experimental: High dose group
ASP3350 high dose

Intervention: Drug: ASP3350
Experimental: Low dose group
ASP3350 low dose

Intervention: Drug: ASP3350

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

155

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01261572

Other Study ID Numbers ^ICMJE

3550-CL-0009

Has Data Monitoring Committee

Yes

Responsible Party

Astellas Pharma Inc

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Use Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

December 2011

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

To Top