The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
942
Arizona Oncology Associates, PC-HAL
Pheonix, Arizona, United States
The Oncology Institute of Hope and Innovation
Downey, California, United States
Compassionate Cancer Medical Center
Riverside, California, United States
Northern Indiana Research
Mishawaka, Indiana, United States
Delayed Phase Complete Response (CR) Rate
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
Time frame: 24 - 120 Hours
Overall Complete Response Rate
To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.
Time frame: 0 - 120 Hours
Delayed Complete Control (CC) Rate
To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes \[vomiting or retching\], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.
Time frame: 24 - 120 Hours
Overall Complete Control Rate
To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes \[vomiting or retching\], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.
Time frame: 0 - 120 Hours
Rate of No Emetic Episodes
To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.
Time frame: 0 - 120 Hours
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Northern Indiana Research
South Bend, Indiana, United States
North Shore Oncology
East Setauket, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States