A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
|First Received Date ICMJE||February 28, 2012|
|Last Updated Date||January 17, 2013|
|Start Date ICMJE||March 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The rate of suppression of serum testosterone to castrate level [ Time Frame: From the start of study drug administration through Week 48 ] [ Designated as safety issue: No ]
Comparison of the proportion of patients maintained at castration level
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01546623 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy|
|Official Title ICMJE||Not Provided|
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in prostate cancer patients previously treated with hormonal therapy.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Prostate Cancer|
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||164|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
（1） Renal function: serum creatinine level< 1.5 times the upper limit of normal (ULN) （2） Bone-marrow function: white blood count ≥ 3,500/ mm3, platelet count ≥ 100,000/L, hemoglobin ≥ 10.0g/dL （3） Hepatic function: AST(GOT), ALT(GPT), ALP and total bilirubin ≤ 2.5 times the ULN 10. The participant's life expectancy is at least 24 months at informed consent.
（1） Radiotherapy. As for I-125 brachytherapy, within 35 weeks (245 days) prior to study enrollment.
（2） Prostatectomy （3） Experimental therapy including high-intensity focused ultrasound therapy (HIFU), immunotherapy, and gene therapy 11. Patients who received the following drugs within 4 weeks (28 days) before starting the study drug: Testosterones, ketoconazole（except for external preparations）, spironolactone, corticosteroids (excluding their inhalants and external preparations), and Chinese medicines and dietary supplements containing saw palmetto 12. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening 13. The participant has a history of hypersensitivity to synthetic LHRH, LHRH derivative or any component of the study drug.
14. The participant has central nervous system metastasis which requires treatment or which is symptomatic.
15. The participant already has a history or has a complication or may have renal disorder caused by spinal cord compression or ureteric obstruction.
16. The participant has a history of serious drug allergic reaction/hypersensitivity 17. The participant has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure
|Ages||20 Years to 85 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Japan|
|NCT Number ICMJE||NCT01546623|
|Other Study ID Numbers ICMJE||TAP-144-SR(6M)IP/CPH-002, U1111-1128-6861, JapicCTI-121763|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )|
|Study Sponsor ICMJE||Takeda Pharmaceutical Company Limited|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Takeda Global Research & Development Center, Inc.|
|Verification Date||January 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP