Chemotherapy Induced Nausea and Vomiting MedDRA version: 9.1 Level: LLT Classification code 10054133 Term: Prophylaxis of nausea and vomiting
Conditions
Interventions
Product Name: APF530
Product Code: 2% granisetron TEG-POE Polymer formulation
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GRANISETRON
CAS Number: 109889090
Current Sponsor code: A
Sponsors
A.P. Pharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and main criteria for inclusion and exclusion: Subject Population: Male or female subjects = 18 years of age, with histologically or cytologically confirmed malignant disease, and scheduled to receive single-day administrations of moderately or highly emetogenic chemotherapy (determined using the Hesketh algorithm). Administration of chemotherapy should not extend beyond 4 hours excluding administration of monoclonal antibodies. Chemotherapy administrations must be separated by at least 7 days but should not be more than 28(+3) days apart. Study drug administrations cannot be more than 28(+ 3) days apart. Inclusion: Men and women 18 years of age or older who are scheduled to receive moderately emetogenic (Hesketh Level 3 and 4) or highly emetogenic (Hesketh Level 5) chemotherapy; have histologically or cytologically confirmed malignant disease; are able to receive the standardized doses of dexamethasone, as required by this protocol; have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; are willing and able to comply with all testing and requirements defined in this protocol; are willing and able to provide voluntary, written, informed consent to participate in this study, and the ability to fully understand the study requirements. Eligible patients are not required to be chemotherapy naïve. Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study. It is recommended that females and female partners of male subjects remain adequately protected from conception for up to one year following study participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion: Treatment with chemotherapeutic regimens which are mildly or unlikely to be emetogenic (Hesketh Level 1 and 2); allergy or hypersensitivity to 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists or to local anesthetics; ECOG performance status of 3, 4 or 5; head and neck cancers that have compromised the brain vomiting and nausea centers, primary brain tumors and active/symptomatic brain metastases, or GI cancers with gastric or intestinal obstruction that may result in symptoms of nausea and vomiting; a psychological problem that, in the investigator’s opinion, is severe enough to preclude reliable study participation; recent history (within 1 year) of alcohol or drug abuse; greater than mild nausea or any vomiting within 24 hours prior to study drug administration; pregnancy (confirmed by serum or urine test) or breastfeeding; any concomitant condition that, in the opinion of the investigator, could affect assessment of the study drug or could interfere with the nausea/vomiting response, including severe renal or hepatic impairment; use of investigational drug within 30 days before study entry; subjects with QTc interval > 500 msec or with a cardiac abnormality predisposing the subject to arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to evaluate in the first qualifying chemotherapy treatment the efficacy of a single dose of a sustained release formulation of granisetron (APF530) in comparison to Aloxi® for the prevention of acute-onset and delayed-onset CINV in subjects currently undergoing moderately or highly emetogenic chemotherapy: 1. To test the non-inferiority of APF530 for the prevention of acute-onset CINV following administration of either moderately emetogenic or highly emetogenic chemotherapy in comparison to Aloxi®. 2. To test the non-inferior efficacy of APF530 for the prevention of delayed-onset CINV following administration of moderately emetogenic chemotherapy in comparison to Aloxi®. 3. To test the superior efficacy of APF530 for the prevention of delayed-onset CINV following administration of highly emetogenic chemotherapy in comparison to Aloxi® ;Secondary Objective: The secondary objectives are to evaluate the safety and tolerability, sustained efficacy, and pharmacokinetics of APF530 in subjects undergoing moderately or highly emetogenic chemotherapy over multiple qualifying chemotherapy treatments: 1. To evaluate the safety and tolerability of APF530 for the prevention of acute-onset and delayed-onset CINV following administration of the first and subsequent chemotherapy treatments. 2. To evaluate the efficacy of APF530 for the prevention of acute-onset and delayed-onset CINV during multiple chemotherapy treatments. 3. To gather pharmacokinetic APF530 data in a subset of subjects undergoing moderately or highly emetogenic chemotherapy during the first study drug treatment. This substudy is not being conducted in Poland (or the Community) per Protocol Addendum #1 dated 2007/08/08. ;Primary end point(s): The following efficacy measures will be evaluated daily during the first 5 days after administration of chemotherapy: Complete Response (CR): No emetic episodes and no use of rescue medication. Complete Control (CC): | — |
Countries
Poland
Outcome results
None listed