A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

Phase 2

Completed

• Conditions: metastatic; progressive; prostate cancer; 10038593; 10036958; castrationresistant prostate cancer (mCRPC); chemotherapy-naïve

• Registration Number: NL-OMON37312
• Lead Sponsor: Millenium Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Male patients 18 years or older.
2. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
4. Prior surgical castration or concurrent use of an agent for medical castration (eg, GnRH analogue).
5. PSA * 2 ng/mL at screening.
6. Progressive disease based on PSA and/or radiographic criteria.

Exclusion Criteria

1. Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
2. Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
3. All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
4. Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [eg, joint injection] are allowed).
5. Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>* Percentage of patients in Japan with serum testosterone levels reduced to * 2<br /><br>ng/dL after 4 weeks of treatment with orteronel 300 mg BID plus prednisone 5 mg<br /><br>BID, when compared to placebo plus prednisone 5 mg BID</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondairy endpoints:<br /><br>* Percentage of ex-Japan patients with serum testosterone levels reduced to * 2<br /><br>ng/dL after 4 weeks of treatment with orteronel 400 mg BID plus prednisone 5 mg<br /><br>BID, when compared to placebo plus prednisone 5 mg BID<br /><br>* Serum testosterone levels after 4 weeks of treatment with study drug<br /><br>(orteronel plus prednisone or placebo plus prednisone) and after 12 weeks of<br /><br>active treatment with orteronel plus prednisone in all treatment groups</p><br>