{"id":62404,"date":"2025-11-27T18:47:43","date_gmt":"2025-11-27T13:17:43","guid":{"rendered":"https:\/\/mint-money.in\/index.php\/2025\/11\/27\/cliniexperts-successfully-completes-phase-iv-akynzeo-i-v-study-for-glenmark\/"},"modified":"2025-11-27T18:47:43","modified_gmt":"2025-11-27T13:17:43","slug":"cliniexperts-successfully-completes-phase-iv-akynzeo-i-v-study-for-glenmark","status":"publish","type":"post","link":"https:\/\/mint-money.in\/index.php\/2025\/11\/27\/cliniexperts-successfully-completes-phase-iv-akynzeo-i-v-study-for-glenmark\/","title":{"rendered":"CliniExperts Successfully Completes Phase IV Akynzeo\u00ae I.V Study for Glenmark"},"content":{"rendered":"<div>\n<p style=\"text-align: center;\"><em>CliniExperts Research Services Pvt. Ltd<\/em><\/p>\n<p dir=\"ltr\"><strong>New Delhi [India], November 27: <\/strong>CliniExperts Research Services Pvt. Ltd., New Delhi, India, proudly announces the successful completion of Phase IV study on Akynzeo\u00ae I.V for Glenmark Pharmaceuticals Ltd. As a CRO, CliniExperts provided end-to-end Clinical Support, including Site Management and Clinical Operations support.<\/p>\n<p dir=\"ltr\"><span style=\"box-sizing: border-box; margin: 0px; padding: 0px;\"><strong>Study Title:<\/strong> An open-label, single-arm, multicenter, prospective study to evaluate the safety and effectiveness of Akynzeo\u00ae I.V. [Fosnetupitant 235 mg and Palonosetron 0.25 mg (concentrate for solution for infusion)], in the Prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients (STOP-CINV study).<\/span><\/p>\n<h3 dir=\"ltr\">Study Design:<\/h3>\n<ul>\n<li dir=\"ltr\">\n<p dir=\"ltr\">178 adult patients (male or female) aged \u226518 and \u226475 years, scheduled to receive their first cycle of chemotherapy, were enrolled across 6 sites in India. The study was initiated after approval from the institutional ethics committee (CTRI\/2023\/04\/051951).<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">All enrolled patients received IV Akynzeo\u00ae (fosnetupitant 235 mg and palonosetron 0.25 mg) diluted up to 50 mL with either 30 mL of 0.9% sodium chloride or 5% glucose and infused over 30 minutes (initiated 30 minutes before chemotherapy and completed before the start of chemotherapy).<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">The overall observation period was 10 days (\u00b12 days). On Day 1, patients received CINV prophylaxis with dexamethasone at the oncologist\u2019s discretion, followed by nine days of telephonic follow-up to evaluate safety and effectiveness.<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">Assessments were conducted on Day 2 (24 hours), Day 5 (120 hours), and Day 10 (\u00b12 days; 240 hours). Data collected included the timing and duration of each emetic episode, severity of nausea, use of rescue medications, and any adverse events (AEs).<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">The severity of nausea was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm: VAS &lt;5 mm, no nausea; VAS 5 to &lt;25 mm, no significant nausea; VAS 25-74 mm, moderate nausea; and VAS 75-100 mm, severe nausea.<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">Safety monitoring included recording treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).<\/p>\n<\/li>\n<\/ul>\n<h4 dir=\"ltr\">Study Conclusion<\/h4>\n<ul>\n<li dir=\"ltr\">\n<p dir=\"ltr\">IV Akynzeo\u00ae was highly effective in preventing acute, delayed, and extended delayed CINV in cancer patients receiving HEC and MEC regimens.<\/p>\n<\/li>\n<li dir=\"ltr\">\n<p dir=\"ltr\">The combination demonstrated compelling effectiveness and a favorable safety profile, supporting its use as a preferred option for the prevention of CINV. IV Akynzeo\u00ae provides a simple and convenient CINV prophylaxis option, addressing symptoms for up to 10 days after chemotherapy with a single dose administered on Day 1.<\/p>\n<\/li>\n<\/ul>\n<p dir=\"ltr\">Citation:\u00a0Shukla P, Valame S, Nanda S, et al. (September 10, 2025) STOP-CINV Study: Safety and Efficacy of IV Akynzeo\u00ae (Fosnetupitant 235 mg and Palonosetron 0.25 mg) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Indian Patients. Cureus 17(9): e91965. DOI 10.7759\/cureus.91965<\/p>\n<p dir=\"ltr\">Read the full article here:\u00a0<a href=\"https:\/\/cliniexperts-research.com\/news\/evaluate-safety-and-effectiveness-of-akynzeo-i-v\/\" target=\"_blank\" rel=\"noopener\">https:\/\/cliniexperts-research.com\/news\/evaluate-safety-and-effectiveness-of-akynzeo-i-v\/<\/a><\/p>\n<p dir=\"ltr\"><em>If you have any objection to this press release content, kindly contact pr.error.rectification@gmail.com to notify us. We will respond and rectify the situation in the next 24 hours.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>CliniExperts Research Services Pvt. Ltd New Delhi [India], November 27: CliniExperts Research Services Pvt. Ltd., New Delhi, India, proudly announces the successful completion of Phase [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":62405,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[105],"tags":[237],"class_list":["post-62404","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-education","tag-education"],"_links":{"self":[{"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/posts\/62404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/comments?post=62404"}],"version-history":[{"count":0,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/posts\/62404\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/media\/62405"}],"wp:attachment":[{"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/media?parent=62404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/categories?post=62404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mint-money.in\/index.php\/wp-json\/wp\/v2\/tags?post=62404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}