Loading clinical trials...

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy

NCT02106494•Heron Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 87 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Exclusion Criteria

•Subject has a known hypersensitivity to granisetron or any 5-HT3 receptor antagonist.
•Subject has a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 msec in men and \> 470 msec in women on the screening ECG.
•Subject has PR \> 240 msec, QRS \> 110 msec, or a history of prolongation of QT interval.
•Subject has a family history of long QT syndrome.
•Subject has a history of cardiac disease, including congenital long QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, or chest pain or dyspnea on exertion.
•Subject has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia.
•Subject has idiopathic cardiomyopathy, syncope, epilepsy, hypertrophic cardiomyopathy, or other clinically significant cardiac disease.
•Subject is pregnant or breast-feeding.
•Subject is planning to receive multiple-day chemotherapy.
•Subject has taken any of the following agents within 7 days prior to initiation of chemotherapy (the study): 5-HT3 receptor antagonists, phenothiazines, benzamides, domperidone, cannabinoids, or NK-1 receptor antagonist.
+8 more criteria

Locations (7)

Arizona Oncology Associates, PC-HAL

Phoenix, 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

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

Key Dates

Start Date

March 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

March 2, 2026

Enrollment

942

ACTUAL participants

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

APF530

DRUG

Ondansetron

DRUG

Ondansetron placebo

DRUG

APF530 placebo

DRUG

Fosaprepitant

DRUG

Dexamethasone

DRUG

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

NCT01937156

Chemotherapy-induced Nausea and Vomiting

View study

UNKNOWNPHASE2

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

NCT04472143

Chemotherapy-induced Nausea and Vomiting (CINV)

View study

COMPLETEDPHASE1

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

Inclusion Criteria

Exclusion Criteria

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study