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

October 31, 2016 updated by: Heron Therapeutics

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

942

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Pheonix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC-HAL
    • California
      • Downey, California, United States, 90241
        • The Oncology Institute of Hope and Innovation
      • Riverside, California, United States, 92501
        • Compassionate Cancer Medical Center
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Northern Indiana Research
      • South Bend, Indiana, United States, 46804
        • Northern Indiana Research
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Oncology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Dexamethasone
Drug: Fosaprepitant
Drug: APF530
Drug: Ondansetron placebo
Active Comparator: 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
Drug: Dexamethasone
Drug: Ondansetron
Drug: Fosaprepitant
Drug: APF530 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed Phase Complete Response (CR) Rate
Time Frame: 24 - 120 Hours
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
24 - 120 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Complete Response Rate
Time Frame: 0 - 120 Hours
To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.
0 - 120 Hours
Delayed Complete Control (CC) Rate
Time Frame: 24 - 120 Hours
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.
24 - 120 Hours
Overall Complete Control Rate
Time Frame: 0 - 120 Hours
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.
0 - 120 Hours
Rate of No Emetic Episodes
Time Frame: 0 - 120 Hours
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.
0 - 120 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heron Therapeutics

Investigators

  • Study Director: Mark Gelder, MD, Heron Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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