Phase II Study of ASP3550 in Patients With Prostate Cancer
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00568516
First received: December 5, 2007
Last updated: November 10, 2009
Last verified: November 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Drug: ASP3550 |
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 in Patients With Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with testosterone surge [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Percentage change in serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Changes in serum levels of testosterone, LH, FSH and PSA over time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Time to the recurrence of serum PSA [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
| Enrollment: | 273 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1.Low dose group |
Drug: ASP3550
subcutaneous administration
Other Name: Degarelix
|
| Experimental: 2.High dose group |
Drug: ASP3550
subcutaneous administration
Other Name: Degarelix
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 5α-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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568516
Locations
| Japan | |
| Chubu, Japan | |
| Chugoku, Japan | |
| Hokkaido, Japan | |
| Kansai, Japan | |
| Kanto, Japan | |
| Kyusyu, Japan | |
| Shikoku, Japan | |
| Tohoku, Japan | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Central Contact | Astellas Pharma Inc |
More Information
No publications provided
| Responsible Party: | Director, Astellas Pharma, Inc |
| ClinicalTrials.gov Identifier: | NCT00568516 History of Changes |
| Other Study ID Numbers: | 3550-CL-0003 |
| Study First Received: | December 5, 2007 |
| Last Updated: | November 10, 2009 |
| 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 June 18, 2013