progressive castration-resistant prostate cancer. MedDRA version: 16.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Recommended INN-Orteronel
Product Code: TAK-700
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Recommended INN = Orteronel
CAS Number: 566939-85-3
Current Sponsor code: TAK
Sponsors
Millennium Pharmaceuticals, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 3.Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 4.Prior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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in Japan;Secondary Objective: •To evaluate the reduction in serum testosterone levels in ex-Japan patients administered orteronel 400 mg BID plus prednisone 5 mg BID, when compared to placebo plus prednisone 5 mg BID •To determine whether orteronel plus prednisone improves 50% prostate-specific antigen (PSA) response •To evaluate the effect of orteronel plus prednisone on endocrine markers of pharmacodynamic response •To characterize the pharmacokinetics of orteronel plus prednisone •To continue to assess the safety of orteronel plus prednisone in patients with castration resistant prostate cancer (CRPC) Exploratory •To explore the pharmacokinetic (PK) -pharmacodynamic response to orteronel plus prednisone in patients in Japan and ex-Japan ;Primary end point(s): Percentage of patients in Japan with serum testosterone levels reduced to = 2 ng/dL after 4 weeks of treatment with orteronel 300 mg BID plus prednisone 5 mg BID, when compared to placebo plus prednisone 5 mg BID;Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Percentage of ex-Japan patients with serum testosterone levels reduced to = 2 ng/dL after 4 weeks of treatment with orteronel 400 mg BID plus prednisone 5 mg BID, when compared to placebo plus prednisone 5 mg BID •Serum testosterone levels after 4 weeks of treatment with study drug (orteronel plus prednisone or placebo plus prednisone) and after 12 weeks of active treatment with orteronel plus prednisone in all treatment groups •PSA reduction = 50% after 4 weeks of treatment with study drug (orteronel plus prednisone or placebo plus prednisone) and after 12 weeks of active treatment with orteronel plus prednisone in all treatment groups •Pharmacodynamic effects of orteronel as measured by endocrine markers dehydroepiandrosterone sulfate (DHEA-S), ACTH, corticosterone, and cortisol in all treatment groups •PK parameters, including, but not limited to, Cmax, AUC from zero to 24 hours (AUC24hr), AUCinf, single dose first time of occurrence of maximum (peak) concentration (Tmax), and the cumulative amount of unchanged drug excreted into the urine (Ae) in all treatment groups •Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, vital sign measurements, physical examination findings, and electrocardiograms (ECGs) in all treatment groups ;Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day] | — |
Countries
Australia, Austria, Germany, Greece, Ireland, Italy, Japan, Netherlands, New Zealand, Portugal, United Kingdom, United States
Contacts
Public ContactDrug Information Call Center
Millenium, Drug Information Call Center
Outcome results
None listed