A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients R… (NCT02106494) | Clinical Trial Compass
CompletedPhase 3
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
United States942 participantsStarted 2014-03
Plain-language summary
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
Who can participate
Age range18 Years – 87 Years
SexALL
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Inclusion Criteria:
* Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment.
* Subjects must have histologically or cytologically confirmed malignant disease.
* Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guidelines for further details on the emetogenic classifications of chemotherapy agents for this study).
* A life expectancy \> 6 months
* Subjects must be able to receive standardized doses of dexamethasone as required in the protocol for the prevention of emesis.
* Subjects must be characterized as having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subjects must have adequate bone marrow, kidney, and liver function.
* Subjects must be able to swallow oral medications (pills) without difficulty.
* Subjects must be entering the first cycle of their current chemotherapy regimen.
* Subjects must be willing and able to comply with all testing and requirements defined in the protocol.
* Subjects must be able to provide voluntary, written, informed consent to participate in this study and must be able to fully understand the study requirements.
* Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study, using at least one form of contraception. It is recommended that females and female partners of male subjects remain adequately protected from conception during the study and for up to 1 year following study p…