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

NCT ID: NCT02106494

Last Updated: 2016-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 942 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-05-31

Brief 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

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Highly emetogenic chemotherapy (HEC); Chemotherapy-Induced Nausea and Vomiting (CINV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

APF530 500 mg SC

APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC

Group Type: EXPERIMENTAL

APF530

Intervention Type: DRUG

Ondansetron placebo

Intervention Type: DRUG

Fosaprepitant

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

ondansetron 0.15 mg/kg IV

Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

APF530 placebo

Intervention Type: DRUG

Fosaprepitant

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

APF530

Intervention Type: DRUG

Ondansetron

Intervention Type: DRUG

Ondansetron placebo

Intervention Type: DRUG

APF530 placebo

Intervention Type: DRUG

Fosaprepitant

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

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 participation.

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.
• Subject has taken any benzodiazepine within 1 day (24 hours) prior to initiation of chemotherapy (the study).
• Subject is scheduled to receive any other chemotherapeutic agent from Day 2 through Day 6.
• Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
• Subject has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study, except as premedication for chemotherapy (e.g., taxanes, pemetrexed).
• Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
• Subject has ongoing vomiting, retching, or nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
• Subject has vomited and/or has had dry heaves or retching within 24 hours prior to the start of HEC on Day 1.
• Subject is NOT able to swallow oral medications (pills) without difficulty.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heron Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Gelder, MD

Role: STUDY_DIRECTOR

Heron Therapeutics

Locations

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

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

Countries

United States

References

Schnadig ID, Agajanian R, Dakhil C, Gabrail NY, Smith RE Jr, Taylor C, Wilks ST, Schwartzberg LS, Cooper W, Mosier MC, Payne JY, Klepper MJ, Vacirca JL. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016 Jun;12(12):1469-81. doi: 10.2217/fon-2016-0070. Epub 2016 Mar 21.

Reference Type: RESULT

PMID: 26997579 (View on PubMed)

Other Identifiers

C2013-01

Identifier Type: -

Identifier Source: org_study_id