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)

The study is a prospective, open label, multicenter, single arm, phase IV study to evaluate the safety and effectiveness of Akynzeo® I.V. in the management of patients receiving highly emetogenic chemotherapy (HEC)/ moderately emetogenic chemotherapy (MEC) regimen for the prevention of CINV among Indian patients. The study would be initiated at each site after review and approval from ethics committee (IRB/IEC). At screening & baseline, the potential patients both male, female more than or equal to 18 years of age, scheduled for first cycle of chemotherapy, will be enrolled in the study and a written informed consent would be procured before any study related procedures are undertaken. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. The clinical and laboratory assessment as per schedule of assessments (Table 2) would be performed at screening for determining the eligibility. Subjects would be administered the study drug on site by the Investigator and Visual Analog Scale (VAS) handout will be given to the patient.