A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01546623
First received: February 28, 2012
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: TAP-144-SR(6M)
Drug: TAP-144-SR(3M)
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 164
Study Start Date: March 2012
Arms Assigned Interventions
Experimental: TAP-144-SR(6M)
TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
Drug: TAP-144-SR(6M)
Active Comparator: TAP-144-SR(3M)
TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
Drug: TAP-144-SR(3M)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participant has histopathologically confirmed prostate cancer in Japanese.
  2. The participant has prostate cancer in the clinical stages of T1b-T4, N-any and M-any by TNM classification on clinical diagnosis at the time of diagnosis.
  3. The participant has ECOG performance status of grades 0, 1, or 2 at screening.
  4. The participant with PSA level which has not increased 25 % or greater and 2 ng/mL or more from the nadir at the measurement points 4 weeks or longer apart within the screening period of 12 weeks.
  5. Patients who receive the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) at screening
  6. Patients who have received the marketed products, TAP-144-SR (1M) and TAP-144-SR (3M), for 24-96 weeks in total at the scheduled starting date of the study drug, but not including administration period treated as neoadjuvant therapy for prostatectomy and/or radiation therapy
  7. Patients who have continued the nonsteroidal antiandrogen for longer than 12 weeks at the scheduled starting date of the study drug, if a nonsteroidal antiandrogen is concomitantly administered
  8. The participant with a serum testosterone level at screening < 100ng/dL
  9. The participant meets the following criteria of renal, bone-marrow and hepatic functions on the laboratory test results at screening:

(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.

Exclusion Criteria:

  1. The participant has active multiple primary cancers, (synchronous multiple primary cancer or metachronous multiple primary cancer with the disease-free survival ≤ 5 years)
  2. The participant has received surgical castration.
  3. The participant has ever received LHRH agonists other than commercially available 1-month or 3-month depot of leuprolide acetate.
  4. The participant has ever received LHRH antagonists.
  5. Patients who have previously received estrogen preparations or corticosteroids for prostate cancer
  6. Patients who have previously received chemotherapy for prostate cancer
  7. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) or the marketed products for 1 month (LEUPLIN FOR INJECTION 3.75 and KIT 3.75) as an adjuvant therapy after prostatectomy and/or radiotherapy
  8. Patients who are receiving or received the marketed product for 3 months (LEUPLIN SR FOR INJECTION KIT 11.25) for intermittent androgen deprivation therapy
  9. Patients who received the following drugs within 24 weeks (168 days) after starting the study drug: Steroidal antiandrogens, type II 5α-reductase inhibitors
  10. The participant received any of the following within 16 weeks (112 days) prior to study enrollment:

(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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546623

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 medicalinformation@tpna.com

Locations
Japan
Recruiting
Nagoya-shi, Aichi, Japan
Recruiting
Chiba-shi, Chiba, Japan
Recruiting
Fukuoka-shi, Fukuoka, Japan
Recruiting
Maebashi-shi, Gunma, Japan
Recruiting
Sapporo-shi, Hokkaido, Japan
Active, not recruiting
Kanazawa-shi, Ishikawa, Japan
Recruiting
Yokohama-shi, Kanagawa, Japan
Recruiting
Sendai-shi, Miyagi, Japan
Recruiting
Nigata-shi, Nigata, Japan
Recruiting
Osaka-shi, Osaka, Japan
Recruiting
Suita-shi, Osaka, Japan
Active, not recruiting
Ageo-shi, Saitama, Japan
Active, not recruiting
Kita-adachi-gun, Saitama, Japan
Recruiting
Shizuoka-shi, Shizuoka, Japan
Active, not recruiting
Itabashi-ku, Tokyo, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01546623     History of Changes
Other Study ID Numbers: TAP-144-SR(6M)IP/CPH-002, U1111-1128-6861, JapicCTI-121763
Study First Received: February 28, 2012
Last Updated: October 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014