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Orteronel

DRUG9 trials

Sponsors

Millennium Pharmaceuticals, Inc., European Organisation for Research and Treatment of Cancer - EORTC, Swiss Cancer Institute, University of Southern California, SCRI Development Innovations, LLC

Conditions

Adenocarcinoma of the ProstateCastration-resistant Prostate CancerHormone-resistant Prostate CancerMetastatic Breast CancerProstate CancerRecurrent Prostate CancerStage IV 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 Ib/II Study Evaluating Orteronel (Without Prednisone) Combined With Itraconazole In Men With Castration-Resistant Prostate Cancer (CRPC)
WithdrawnNCT02054793
Emmanuel Antonarakis, MDCastration-resistant Prostate Cancer, Prostate Cancer
Start: 2014-06-30End: 2016-07-31Updated: 2014-07-23

Phase 2

TAK-700 in Castration Resistant Prostate Cancer
WithdrawnNCT01658527
European Organisation for Research and Treatment of Cancer - EORTCProstate Cancer
Start: 2014-01-31End: 2017-01-31Updated: 2016-06-10
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
TerminatedNCT01866423
University of Southern CaliforniaAdenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer +1
Start: 2013-10-25End: 2016-07-26Updated: 2017-08-31
Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
CompletedNCT01990209
SCRI Development Innovations, LLCMetastatic Breast Cancer
Start: 2014-03-31End: 2021-05-01Updated: 2022-06-30

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
Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
CompletedNCT01193244
Millennium Pharmaceuticals, Inc.Prostate Cancer
Start: 2010-10-01End: 2016-04-07Updated: 2017-05-17
Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy
CompletedNCT01707966
Swiss Cancer InstituteProstate Cancer
Start: 2012-09-30End: 2016-07-31Updated: 2019-05-15
Orteronel Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents
WithdrawnNCT02053311
Swiss Cancer InstituteProstate Cancer
Start: 2014-08-19End: 2034-08-19Updated: 2018-07-30

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
Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial.
2015-02-18101 citations
Phase 3, randomized, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients (pts) with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) (ELM-PC 4 trial)
Journal of Clinical Oncology2014-05-2023 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