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 greater than or equal to 18 and less than or equal to 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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