NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
405
Percentage of Patients With Adverse Events
This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.
Time frame: Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
Time frame: 0-24 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
Time frame: >24-120 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
Time frame: 0-120 hours
Percentage of Patients With no Emetic Episodes in the Acute Phase
Time frame: 0-24 hours
Percentage of Patients With no Emetic Episodes in the Delayed Phase
Time frame: >24-120 hours
Percentage of Patients With no Emetic Episodes in the Overall Phase
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Time frame: 0-120 hours
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase
Time frame: 0-24 hours
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase
Time frame: >24-120 hours
Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase
Time frame: 0-120 hours