SMPL
New Delhi [India], November 28: CliniExperts Research Services Pvt. Ltd., New Delhi, India proudly announces the successful completion of Phase IV study on Akynzeo® I.V for Glenmark Pharmaceuticals ltd. As a CRO, CliniExperts provided end to end Clinical Support including Site Management and Clinical Operations support.
Study Title: An open label, single arm, multicenter, prospective study to evaluate safety and effectiveness of Akynzeo® 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).
Study Design:
- 178 adult patients (male or female) aged >=18 and <=75 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).
- All enrolled patients received IV Akynzeo® (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).
- The overall observation period was 10 days (+-2 days). On Day 1, patients received CINV prophylaxis with dexamethasone at the oncologist's discretion, followed by nine days of telephonic follow-up to evaluate safety and effectiveness.
- Assessments were conducted on Day 2 (24 hours), Day 5 (120 hours), and Day 10 (+-2 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).
- The severity of nausea was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm: VAS <5 mm, no nausea; VAS 5 to <25 mm, no significant nausea; VAS 25-74 mm, moderate nausea; and VAS 75-100 mm, severe nausea.
- Safety monitoring included recording treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).
Study Conclusion
- IV Akynzeo® was highly effective in preventing acute, delayed, and extended delayed CINV in cancer patients receiving HEC and MEC regimens.
- The combination demonstrated compelling effectiveness and a favorable safety profile, supporting its use as a preferred option for the prevention of CINV. IV Akynzeo® 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.
Citation: Shukla P, Valame S, Nanda S, et al. (September 10, 2025) STOP-CINV Study: Safety and Efficacy of IV Akynzeo® (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
Read the full article here: https://cliniexperts-research.com/news/evaluate-safety-and-effectiveness-of-akynzeo-i-v/
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