By a News Reporter-Staff News Editor at Clinical Trials Week -- Data detailed on Clinical Research have been presented. According to news reporting originating from Nashville, Tennessee, by NewsRx correspondents, research stated, "The androgen receptor pathway remains active in men with prostate cancer whose disease has progressed following surgical or medical castration. Orteronel (TAK-700) is an investigational, oral, nonsteroidal, selective, reversible inhibitor of 17,20-lyase, a key enzyme in the production of androgenic hormones."
Our news editors obtained a quote from the research from Cancer Research Institute, "We conducted a phase I/II study in men with progressive, chemotherapy-naive, metastatic castration-resistant prostate cancer, and serum testosterone <50 ng/dL. In the phase I part, patients received orteronel 100 to 600 mg twice daily or 400 mg twice a day plus prednisone 5 mg twice a day. In phase II, patients received orteronel 300 mg twice a day, 400 mg twice a day plus prednisone, 600 mg twice a day plus prednisone, or 600 mg once a day without prednisone. In phase I (n = 26), no dose-limiting toxicities were observed and 13 of 20 evaluable patients (65%) achieved >= 50% prostate-specific antigen (PSA) decline from baseline at 12 weeks. In phase II (n = 97), 45 of 84 evaluable patients (54%) achieved a>= 50% decline in PSA and at 12 weeks, substantial mean reductions from baseline in testosterone (-7.5 ng/dL) and dehydroepiandrosterone-sulfate (-45.3 mg/dL) were observed. Unconfirmed partial responses were reported in 10 of 51 evaluable phase II patients (20%). Decreases in circulating tumor cells were documented. Fifty-three percent of phase II patients experienced grade >= 3 adverse events irrespective of causality; most common were fatigue, hypokalemia, hyperglycemia, and diarrhea."
According to the news editors, the research concluded: "17,20-Lyase inhibition by orteronel was tolerable and results in declines in PSA and testosterone, with evidence of radiographic responses."
For more information on this research see: Phase I/ II Trial of Orteronel (TAK-700)-an Investigational 17,20-Lyase Inhibitor-in Patients with Metastatic Castration-Resistant Prostate Cancer. Clinical Cancer Research, 2014;20(5):1335-1344. Clinical Cancer Research can be contacted at: Amer Assoc Cancer Research, 615 Chestnut St, 17TH Floor, Philadelphia, PA 19106-4404, USA. (American Association for Cancer Research - www.aacr.com; Clinical Cancer Research - clincancerres.aacrjournals.org/)
The news editors report that additional information may be obtained by contacting R. Dreicer, Sarah Cannon Canc Res Inst, Nashville, TN, United States. Additional authors for this research include D. MacLean, A. Suri, W.M. Stadler, D. Shevrin, L. Hart, G.R. MacVicar, O. Hamid, J. Hainsworth, M.E. Gross, Y.J. Shi, I.J. Webb and D.B. Agus (see also Clinical Research).
Keywords for this news article include: Drugs, Oncology, Nashville, Tennessee, Chemotherapy, United States, Prostate Cancer, Clinical Research, Prostatic Neoplasms, North and Central America, Clinical Trials and Studies
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