12 completed, 4 terminated, 3 withdrawn. 12 Phase 2, 6 Phase 3, 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 4, Withdrawn 2 |
| Phase 3 | 6 | Completed 5, Withdrawn 1 |
| Phase 1 | 5 | Completed 4, Withdrawn 1 |
Follow orteronel: new trials by email Literature Review of orteronel trials Research Report on orteronel
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Orteronel Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents Orteronel, Placebo - Prostate Cancer | Phase 3 | Withdrawn | Swiss Cancer Institute | 2014-08-19 | 2018-07-30 | |
| Phase Ib/II Study Evaluating Orteronel (Without Prednisone) Combined With Itraconazole In Men With Castration-Resistant Prostate Cancer (CRPC) Itraconazole, Orteronel - Prostate Cancer, Castration-resistant Prostate Cancer | Phase 1 / Phase 2 | Withdrawn | Emmanuel Antonarakis, MD | 2014-06-01 | 2014-07-23 | |
| Orteronel (TAK-700) in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors. The Greko II Study. Orteronel 300mg BID - Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors | Phase 2 | Terminated | Grupo Español de Tumores Huérfanos e Infrecuentes | 10 | 2014-06-01 | 2018-03-05 |
| Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR) Orteronel - Metastatic Breast Cancer | Phase 2 | Completed | SCRI Development Innovations, LLC | 71 | 2014-03-01 | 2022-06-30 |
| TAK-700 in Castration Resistant Prostate Cancer Orteronel, Bicalutamide - Prostate Cancer | Phase 2 | Withdrawn | European Organisation for Research and Treatment of Cancer - EORTC | 2014-01-01 | 2016-06-10 | |
| Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer orteronel, laboratory biomarker analysis - Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer | Phase 2 | Terminated | University of Southern California | 4 | 2013-10-25 | 2017-08-31 |
| NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis TAK-700, Fluorine F 18 Sodium Fluoride, Positron Emission Tomography - Prostatic Neoplasms, Prostate Cancer | Phase 2 | Terminated | University of Wisconsin, Madison | 8 | 2013-05-01 | 2019-12-09 |
| S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer TAK-700, Bicalutamide - Prostate Cancer | Phase 3 | Completed | SWOG Cancer Research Network | 1313 | 2013-03-08 | 2025-12-31 |
| A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone TAK-700 and LHRH agonist, prostatectomy - Prostate Cancer | Phase 2 | Terminated | Centre of Experimental Medicine | 16 | 2013-02-18 | 2017-07-07 |
| A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer TAK700 - Post Menopausal, Hormone Receptor Positive Breast Cancer | Phase 1 | Completed | University of Wisconsin, Madison | 8 | 2012-11-01 | 2019-11-18 |
| Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy Orteronel, Placebo - Prostate Cancer | Phase 3 | Completed | Swiss Cancer Institute | 47 | 2012-09-01 | 2019-05-15 |
| 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 Orteronel, Orteronel Placebo, Prednisone - Prostate Cancer | Phase 1 / Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 137 | 2012-08-20 | 2018-03-20 |
| Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer Orteronel+Prednisone - Prostate Cancer | Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 50 | 2012-05-01 | 2016-06-01 |
| Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer GnRH agonist, Anti-androgen, TAK-700 - Prostate Cancer | Phase 3 | Completed | Radiation Therapy Oncology Group | 239 | 2012-05-01 | 2026-03-06 |
| Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer. Orteronel, Prednisone, Orteronel Placebo - Prostate Cancer | Phase 3 | Completed | Millennium Pharmaceuticals, Inc. | 1099 | 2010-11-15 | 2018-12-19 |
| Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer Orteronel, Placebo, Prednisone - Prostate Cancer | Phase 3 | Completed | Millennium Pharmaceuticals, Inc. | 1560 | 2010-10-01 | 2017-05-17 |
| Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer TAK-700, Docetaxel, Prednisone - Prostate Cancer | Phase 1 / Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 38 | 2010-07-01 | 2019-07-30 |
| Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen TAK-700 - Prostate Cancer | Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 38 | 2010-05-01 | 2016-04-04 |
| Safety Study of TAK-700 in Subjects With Prostate Cancer. TAK-700 - Prostatic Neoplasms | Phase 1 / Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 123 | 2008-04-01 | 2016-04-04 |
Prostatic Neoplasms (16) · Neoplasm Metastasis (4) · Breast Neoplasms (2) · Granulosa Cell Tumor (1) · Triple Negative Breast Neoplasms (1)
Millennium Pharmaceuticals, Inc. (7) · Swiss Cancer Institute (2) · University of Wisconsin, Madison (2) · Centre of Experimental Medicine (1) · Emmanuel Antonarakis, MD (1) · European Organisation for Research and Treatment of Cancer - EORTC (1) · Grupo Español de Tumores Huérfanos e Infrecuentes (1) · Radiation Therapy Oncology Group (1) · SCRI Development Innovations, LLC (1) · SWOG Cancer Research Network (1) · University of Southern California (1)
United States (14) · Belgium (3) · Canada (3) · Spain (3) · Switzerland (3) · Australia (2) · Czechia (2) · Finland (2) · France (2) · Greece (2) · Italy (2) · Netherlands (2) · Poland (2) · United Kingdom (2) · Austria (1)
Richard Cathomas, MD (2) · Silke Gillessen, Prof (2) · Alicia Hurtado, MD (1) · Amye J Tevaarwerk, MD (1) · Ana Santaballa, MD (1) · Bertrand Tombal (1) · Cora Sternberg (1) · Howard A Burris, III, MD (1) · Isabel Bover, MD (1) · Juan Cueva, MD (1) · Justine Y Bruce, MD (1)
PMID 26031410, PMID 29272162, PMID 24965748, PMID 25624429, PMID 25701170, PMID 27457964, PMID 35446628, PMID 37526936, PMID 38424319, PMID 38980676, PMID 39738931
P30CA014089 (1)