Patients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)
Conditions
Interventions
Trade Name: Akynzeo
Product Name: Akynzeo
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Netupitant
Other descriptive name: NETUPITANT
Concentration unit: µCi/mg microcurie(s)/milligram
Conce
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients aged =18 years - Patients with a risk score of = 13 as calculated by the algorithm (specified in protocol) - Signed Informed consent - Both sexes - Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy - Patients with ECOG performance status 0, 1 or 2 - Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention - Naïve and non- naïve to chemotherapy - Able to comply with study requirements 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: -Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy) -Patients receiving oral moderately emetogenic chemotherapy drugs -Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed) -Use of olanzapine as prophylaxis of CINV - Patients scheduled to receive radiotherapy concurrently with chemotherapy -Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. -Patients with mechanical risk factors for nausea (i.e. intestinal obstruction) -Patients with liver disease (as nausea is a common presenting symptom) -Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting) -Chronic treatment with steroids (with the exception of inhaled or topical steroids) -Pregnancy and/or breast-feeding women -Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than standard of care antiemetics over three cycles of chemotherapy;Secondary Objective: 2. Evaluate acute, delayed, and overall CINV indicators in each cycle of chemotherapy 3. Evaluate the predictive role of potential risk factors in the development of CINV over three cycles of chemotherapy 4. Evaluate the safety profile of the antiemetic drug over three cycles of chemotherapy 5. Explore the effect of CINV on daily activities and quality of life in patients receiving moderately-emetogenic chemotherapy over three cycles of chemotherapy 6. Evaluate resource utilization and health economic outcome ;Primary end point(s): The primary endpoint will be the proportion of complete responses (no emetic episode and no rescue medication) over three cycles of chemotherapy after the start of the MEC administration.;Timepoint(s) of evaluation of this end point: Measured at patients last visit following 3 chemotherapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Complete response during the acute (0-24h), delayed phase (25-120h), overall (0-120h) and daily in each cycle; • No emetic episode during the acute, delayed and overall phase and daily in each cycle; • Number of vomiting episodes during the acute, delayed and overall phase in each cycle; • No rescue medication during the acute, delayed and overall phase and daily in each cycle; • No significant nausea (maximum MAT scale = 2) during the acute, delayed and overall phase and daily in each cycle; • No nausea (MAT scale = 0) during the acute, delayed and overall phase and daily in each cycle; • Complete protection (no emetic episode, no rescue medication and no significant nausea) during the acute, delayed and overall phase and daily in each cycle • Nausea and Vomiting-related quality of life indicators (through the Functional Living Index Emesis scale) • Collection of chemotherapy delays and/or dose reductions (Delay of chemotherapy administration due to CINV will be also evaluated as part of health economic endpoints, see below) ClNV outcomes data will be prospectively collected over the first 5 days of chemotherapy and for three consecutive cycles using standardized Patient's diaries translated in local languages The following health economic endpoints will be evaluated during the study cycles: MHRA Medicines (EudraCT application form) IRAS Version 5.13 12 DRAFT • Number of days and daily doses of rescue medication administered for the treatment of CINV • Number of re-hydration bags given for at least grade 2 vomiting (CTCAE vS) • The number of days of unplanned hospitalisations related to CINV and department of hospitalization (type of ward) • The number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner) • The number of unplanned laboratory test including those at unplanned hospitalisations due to CINV • Discontinuation of chemotherapy treatment due to CINV • Delay of chemotherapy administ | — |
Countries
China, Czech Republic, Germany, Greece, Spain, Switzerland, United Kingdom
Contacts
Public ContactMyRisk information
Institut biostatistiky a analýz, s.r.o.
Outcome results
None listed