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

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ClinicalTrials.gov Identifier: NCT02106494
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Study Description
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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

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: APF530 Drug: Ondansetron Drug: Ondansetron placebo Drug: APF530 placebo Drug: Fosaprepitant Drug: Dexamethasone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 942 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: APF530
Drug: Ondansetron placebo
Drug: Fosaprepitant
Drug: Dexamethasone
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: Ondansetron
Drug: APF530 placebo
Drug: Fosaprepitant
Drug: Dexamethasone


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106494


Locations
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United States, Arizona
Arizona Oncology Associates, PC-HAL
Pheonix, Arizona, United States, 85016
United States, California
The Oncology Institute of Hope and Innovation
Downey, California, United States, 90241
Compassionate Cancer Medical Center
Riverside, California, United States, 92501
United States, Indiana
Northern Indiana Research
Mishawaka, Indiana, United States, 46545
Northern Indiana Research
South Bend, Indiana, United States, 46804
United States, New York
North Shore Oncology
East Setauket, New York, United States, 11733
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Heron Therapeutics
Investigators
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Study Director: Mark Gelder, MD Heron Therapeutics
More Information
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Publications of Results:

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT02106494    
Other Study ID Numbers: C2013-01
First Posted: April 8, 2014    Key Record Dates
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heron Therapeutics:
Highly emetogenic chemotherapy (HEC)
Chemotherapy-Induced Nausea and Vomiting (CINV)
Additional relevant MeSH terms:
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Granisetron
Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Ondansetron
Fosaprepitant
Aprepitant
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents