Orteronel Placebo

DRUG2 trials

Sponsors

Millennium Pharmaceuticals, Inc.

Conditions

Prostate Cancer

Phase 1

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

CompletedNCT01666314

Millennium Pharmaceuticals, Inc.Prostate Cancer

Start: 2012-08-20End: 2016-09-01Updated: 2018-03-20

Phase 3

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

CompletedNCT01193257

Millennium Pharmaceuticals, Inc.Prostate Cancer

Start: 2010-11-15End: 2016-02-29Updated: 2018-12-19

Related Papers

Development and validation of a novel circulating tumor cell response stratification criteria for metastatic castration-resistant prostate cancer clinical trials.

Journal of Clinical Oncology2025-05-28

Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials

Journal of Clinical Oncology2017-12-22229 citations

Regional differences observed in the phase 3 trial (ELM-PC 5) with orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel.

Journal of Clinical Oncology2014-05-203 citations

Circulating tumor cells (CTCs) and LDH as prognostic factors in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing during or following docetaxel treated in the orteronel phase 3 ELM-PC 5 trial.

Journal of Clinical Oncology2014-05-201 citations

Results from a phase 3, randomized, double-blind, multicenter, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy (ELM-PC 5 trial).

Journal of Clinical Oncology2014-02-0135 citations