Drugs / Orteronel
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01808040 | Nov 2012 → Jul 2014 | hormone receptor-positive breast cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT02054793 | Jun 2014 → Jun 2015 | castration-resistant prostate carcinoma | Emmanuel Antonarakis, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01666314 | Aug 2012 → Sep 2013 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 1/2 | NCT01084655 | Jul 2010 → Jan 2013 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00569153 | Apr 2008 → Jan 2013 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT02101684 | Jun 2014 → Jan 2017 | maligant granulosa cell tumor of ovary | Spanish Group for Research in Orphan, Infrequent Tumors | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01990209 | Mar 2014 → May 2021 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01658527 | Jan 2014 → Jan 2016 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT01866423 | Oct 2013 → Jul 2015 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | University of Southern California | Terminated | No outcome recorded |
| Phase 2 | NCT01816048 | May 2013 → Dec 2015 | prostate cancer | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03211052 | Feb 2013 → Jun 2015 | prostate cancer | Centre of Experimental Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT01549951 | May 2012 → Jan 2015 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01046916 | May 2010 → Jan 2013 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT01809691 | Mar 2013 → Mar 2022 | prostate cancer | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT01707966 | Sep 2012 → Sep 2014 | prostate cancer | Swiss Cancer Institute | Completed | Met primary |
| Phase 3 | NCT01546987 | May 2012 → Nov 2021 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT01193257 | Nov 2010 → May 2013 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 3 | NCT01193244 | Oct 2010 → Jan 2014 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | Mixed |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02053311 Comparator | Aug 2014 | prostate cancer | Swiss Cancer Institute | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-05-16 | Takeda | Results Orteronel Plus Prednisone Improved Progression Free Survival in Men With Chemotherapy-Naïve Metastatic Castration Resistant Prostate Cancer in Phase 3 Study takeda.com ↗ |
All press releases naming this drug 2 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orteronel | “Orteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m\^2), infusion,...” NCT01084655 ↗12“Orteronel (TAK-700) is an investigational, nonsteroidal, oral, inhibitor of androgen synthesis with greater specificity for 17,20-lyase than for 17α-hydroxylase.” PMID 24965748 ↗ Jun 2014 |
| Known as | Orteronel (TAK 700) | “Orteronel (TAK 700)” NCT03211052 ↗ |
| Known as | TAK-700 | “This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with...” NCT01193244 ↗11“Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant...” NCT01666314 ↗ “Open-label phase II clinical trial of orteronel (TAK-700) in metastatic or advanced non-resectable granulosa cell ovarian tumors: the Greko II study (GETHI2013-01).” PMID 39738931 ↗ Dec 2024 “Orteronel (TAK-700) is an investigational, nonsteroidal, oral, inhibitor of androgen synthesis with greater specificity for 17,20-lyase than for 17α-hydroxylase.” PMID 24965748 ↗ Jun 2014 “Orteronel (TAK-700) will be increased to reach the highest dose tolerated in men: 400 mg two times daily.” NCT01808040 ↗ |
| Action | Inhibit | “inhibitor of androgen synthesis” PMID 24965748 ↗ Jun 2014 |
| Modality | Small molecule | “Orteronel, a novel, orally active, selective inhibitor of 17,20-lyase, is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as prostate cancer...” NCT02101684 ↗ |
| Route | Oral | “Tablets administered orally” NCT00569153 ↗ |
| Target | CYP17A1 | “blocking testosterone production via the key enzyme CYP17” NCT02053311 ↗ |