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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221877

Enrollment

Registered

2012-08-07

Start date

2012-08-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-naive castration-resistant prostate cancer

Interventions

investigational material(s) Generic name etc : Orteronel (TAK-700) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - Progressive disease - Prior surgical castration or concurrent use of an agent for medical castration - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

Exclusion criteria: - Received prior chemotherapy for prostate cancer - Documented central nervous system metastases - Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction - Uncontrolled cardiovascular condition as specified in study protocol - Uncontrolled nausea, vomiting or diarrhea

Design outcomes

Primary

Measure	Time frame
Serum Testosterone	—

Secondary

Measure	Time frame
50% prostate specific antigen (PSA) response	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026