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.

• Register: EUCTR
• Last refreshed on: 31 October 2016
• Main ID: EUCTR2012-001539-30-GR
• Date of registration: 08/08/2012
• Prospective Registration: No
• Primary sponsor: Millennium Pharmaceuticals, Inc.
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 24/07/2012
• Target sample size: 144
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001539-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Germany, Greece, Ireland, Italy, Japan, Netherlands, New Zealand, Portugal, United Kingdom, United States

Contacts

• Name: Drug Information Call Center
• Affiliation: Millenium, Drug Information Call Center

• Name: Drug Information Call Center
• Affiliation: Millenium, Drug Information Call Center

Key inclusion & exclusion 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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:
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.



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

progressive castration-resistant prostate cancer.
MedDRA version: 14.1 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)

Intervention(s)

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-700
Other descriptive name: 6-[(7S)-7-hydroxy-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-7-yl]-N-methyl-2-naphthamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Decortin
Product Name: Decortin
Product Code: Prednisone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Current Sponsor code: EMD 15216
Other descriptive name: Decortin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]

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

Secondary ID(s)

C21013

2012-001539-30-IE

Source(s) of Monetary Support

Millenium Pharmaceuticals, Inc.