Study to find out the effects and fate of treatment with Orteronel plus prednisone in Japanese and non Japanese people that have not recieved cancer therapy for prostate cancer.

Phase 1

• Conditions: progressive castration-resistant prostate cancer.; MedDRA version: 16.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001539-30-IE
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-12
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 144

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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 clinical trial of medicinal product
• Study Design: Not specified