Phase II Study of ASP3550 in Patients With Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568516
• Other study ID #: 3550-CL-0003
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: October 28, 2014
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages

• Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included

• Has a serum testosterone level above 1.5 ng/mL at screening

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

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 preceding Screening Visit may be included

• Is being treated with a 5a-reductase inhibitor

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

• Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• ASP3550
subcutaneous administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with serum testosterone =0.5 ng/mL from Day 28 to Day 364 of treatment		1 Year	No
Secondary	Proportion of patients with testosterone surge		1 Year	No
Secondary	Percentage change in serum PSA		1 Year	No
Secondary	Changes in serum levels of testosterone, LH, FSH and PSA over time		1 Year	No
Secondary	Time to the recurrence of serum PSA		1 Year	No

External Links

•   Link to Results on JAPIC - enter 140631 in the JapicCTI-RNo. field