Completed PHASE3 INTERVENTIONAL 2-arm NCT01193244

Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Sponsor: Millennium Pharmaceuticals, Inc.

Conditions Prostate Cancer

Interventions Orteronel Placebo Prednisone

Updated 9 times since 2017 Last updated: Apr 7, 2017 Started: Oct 1, 2010 Primary completion: Jan 1, 2014 Completion: Apr 7, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Prostate Cancer and is currently completed. Millennium Pharmaceuticals, Inc. leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

9 versions recorded

Nov 2025 — Present [monthly]

Completed PHASE3
Sep 2025 — Nov 2025 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jul 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Jul 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Oct 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Millennium Pharmaceuticals, Inc.

Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

A Coruña, Spain , Aarau, Switzerland , Aberdeen, United Kingdom , Amarillo, United States , Amsterdam, Netherlands , Anchorage, United States , Angers, France , Arnhem, Netherlands , Athens, Greece , Auckland, New Zealand and 229 more locations