Completed
`Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC
`Patients (MyRisk) (CINV)
`ClinicalTrials.gov ID NCT04817189
`SponsorHelsinn Healthcare SA
`Information provided by Helsinn Healthcare SA (Responsible Party)
`Last Update Posted 2024-12-04
`Study Details Tab
`Study Overview
`Brief Summary
`MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of
`developing CINV based on a prediction tool. A multinational and multicenter study.
`Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy.
`Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential.
`In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV
`(chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the
`most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by
`Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors
`have been identified and an algorithm has been developed to incorporate these factors into the optimal
`selection of prophylactic antiemetics:
`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer(https://clinicaltrials.gov/about-site/disclaimer) for details.
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 1/26
`HELSINN EXHIBIT 2026
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 26
`
`
`
`
`
`
`
`1.nausea and/or v omiting in the prior cycle of chemotherapy
`2.use of non-pr
`escribed antiemetics at home in the prior cycle of chemotherapy
`3.platinum or anthr
`acycline-based chemotherapy
`4.age < 60 y
`ears
`5.expectations for (anticipating) nausea and/or v
`omiting
`6.<7 h of sleep the night befor
`e chemotherapy
`7.hist
`ory of morning sickness during previous pregnancy
`8.cy
`cle of chemotherapy (A negative association between risk and number of cycles was identified
`where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from
`cycle 3 onward).
`The clinical application of this prediction tool has the potential to be an important resource for
`clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive
`manner.
`Antiemetic guideline recommendations are based on the emetogenic potential of chemotherapy and
`involve 4 levels of classification of intravenous chemotherapy agents, i.e., high, moderate, low and
`minimal; these have been accepted by major organisations. Moderate emetogenic chemotherapy (MEC)
`results in acute vomiting in 30% to 90% of cancer patients in the absence of antiemetic therapy. In
`addition to the chemotherapy type, several patient-related risk factors and clinical characteristics can
`increase CINV risk. These can include use of antiemetics inconsistent with international guidelines,
`younger age, prechemotherapy nausea, no complete CINV response in an earlier cycle, history of
`nausea/vomiting, (trait) anxiety, fatigue experience, and expectations of nausea/vomiting. Other studies
`have largely confirmed some of the key risk factors for CINV (history of vomiting during pregnancy,
`history of motion sickness, age, gender) and added other factors such as (chronic) alcohol
`consumption, body surface area, fewer hours slept the night prior to infusion, or advanced stage cancer.
`Currently, there is a limited consensus surrounding the most relevant patient risk factors that may
`predict CINV risk. Based on a recent study by Dranitsaris et al. eight predictive factors have been
`identified, and an algorithm has been developed to combine these patient-related risk factors into the
`optimal treatment of prophylactic antiemetics. These include:
`1.nausea and/or v
`omiting in the prior cycle of chemotherapy
`2.use of non-pr
`escribed antiemetics at home in the prior cycle of chemotherapy
`3.platinum or anthr
`acycline-based chemotherapy
`4.age < 60 y
`ears
`5.expectations for (anticipating) nausea and/or v
`omiting
`6.<7 h of sleep the night befor
`e chemotherapy
`7.hist
`ory of morning sickness during previous pregnancy
`8.cy
`cle of chemotherapy (A negative association between risk and number of cycles was identified
`where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from
`cycle 3 onward).
`Detailed Description
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 2/26
`Page 2 of 26
`
`
`
`
`
`
`
`Akynzeo®, an oral combination of the neurokinin 1 receptor antagonists (NK1 RA), netupitant and the 5-
`hydroxytryptamine (HT3) receptor antagonists (5-HT3 RA), palonosetron, is recommended by guidelines
`for the prevention of CINV. Akynzeo® has been evaluated in a multicentre, randomised, double-blind,
`double-dummy phase II clinical trial at various dose ranges among 694 cisplatin-treated cancer patients
`from 44 sites (two countries); each NEPA (netupitant-palonosetron) dose significantly improves CINV
`prevention in cancer patients. Similar results were obtained in another international, randomised,
`double-blind and parallel group phase III clinical trial; NEPA prevented CINV in patients receiving MEC.
`The current study primarily aimed to evaluate whether Akynzeo® leads to a higher response rate
`compared with standard care in MEC regimen-treated patients who are identified to be at high risk
`based on the algorithm.
`Official Title
`MyRisk: Efficacy and Safety Evaluation of Oral Akynzeo® in Patients Receiving MEC At High Risk of
`Developing CINV Based on a Prediction Tool: a Multinational and Multicenter Study
`Conditions
`Chemotherapy-induced Nausea and Vomiting
`Intervention / Treatment
`Drug: NEPA (300mg netupitant/0.5mg palonosetron)
`Drug: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR
`Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or
`IV)
`Drug: Dexamethasone, 8 mg (oral) or equivalent IV dose
`Other Study ID Numbers
`Study Start (Actual)
`2021-02-01
`Primary Completion (Actual)
`2024-07-02
`Study Completion (Actual)
`2024-07-02
`Enrollment (Actual)
`414
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 3/26
`Page 3 of 26
`
`
`
`
`
`
`
`Study Type
`Interventional
`Phase
`Phase 4
`Resource links provided by the National Library of Medicine
`MedlinePlus(https://medlineplus.gov/) related topics:  Nausea and
`Vomiting(https://medlineplus.gov/nauseaandvomiting.html)
`Drug Information(https://dailymed.nlm.nih.gov/dailymed/) available for: 
`Dexamethasone(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Dexamethasone)
`Palonosetron(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Palonosetron)
`FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links)
`Contacts and Locations
`This section provides contact details for people who can answer questions about joining this study, and
`information on where this study is taking place.
`To learn more, please see the Contacts and Locations section in How to Read a Study
`Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).
`This study has 19 locations
`China
`Shanghai, China
`Shanghai Chest Hospital
`Shanghai, China
`Shanghai Ninth People´s Hospital
`Shanghai, China
`Shanghai Obstetrics and Gynecology Hospital
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 4/26
`Page 4 of 26
`
`
`
`
`
`
`
`Czechia
`Prague, Czechia
`General University Hospital in Prague
`Praha, Czechia, 14059
`Thomayerova nemocnice
`Germany
`Essen, Germany
`Evang. Kliniken Essen-Mitte
`Mannheim, Germany
`Universitätsmedizin Mannheim
`München, Germany
`München Klinik Neuperlach
`Paderborn, Germany
`Frauenklinik St. Louise
`Potsdam, Germany
`Klinikum Ernst von Bergmann gemeinnützige
`GmbH
`Greece
`Athens, Greece
`Sotiria General Hospital, 3rd Deúpartment of
`Medicine, School of Medicine, National and
`Kapodistrian University of Athens
`Heraklion, Greece
`General University Hospital of Heraklion
`Spain
`A Coruña, Spain, 15006
`Complejo Hospitalario Universitario de A Coruña
`Barcelona, Spain, 0802
`Hospital de la Santa Creu i Sant Pau
`Madrid, Spain, 28007
`Hospital General Universitario Gregorio
`Marañón
`Salamanca, Spain, 37007
`Hospital Universitario de Salamanca
`Switzerland
`Basel, Switzerland
`University Hospital Basel
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 5/26
`Page 5 of 26
`
`
`
`
`
`
`
`Genolier, Switzerland
`Swiss Medical Network - Clinique de Genolier
`United Kingdom
`London, United Kingdom
`The Royal Marsden Hospital
`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.
`For general information about clinical research, read Learn About
`Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 6/26
`Page 6 of 26
`
`
`
`
`
`
`
`Eligibility Criteria
`Description
`Inclusion Criteria:
`Adult patients aged ≥18 years
`Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1.
`Baseline/screening: VISIT 0
`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 Eastern Cooperative Oncology Group (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
`The enrolled women should be a) of non-childbearing potential or b) of childbearing
`potential using reliable contraceptive measures and having a negative urine pregnancy test
`done by health care team within 1-24 hours before dosing the antiemetic treatment in both
`arms and outcome recorded in the medical records
`Able to comply with study requirements
`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
`Women of childbearing potential refusing to use effective contraception during the whole
`study treatment and up to one month after study treatment with Akynzeo®
`Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 7/26
`Page 7 of 26
`
`
`
`
`
`
`
`Ages Eligible for Study
`18 Years and older (Adult,  Older Adult)
`Sexes Eligible for Study
`All
`Accepts Healthy Volunteers
`No
`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 : Supportive Care
`Allocation : Randomized
`Interventional Model : Parallel Assignment
`Interventional Model Description: interventional, open label, randomized, active controlled,
`parallel arms, multicenter and multinational study
`Masking : None (Open Label)
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 8/26
`Page 8 of 26
`
`
`
`
`
`
`
`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Experimental: NEPA
`(300mg
`netupitant/0.5mg
`palonosetron) +
`Dexamethasone 8 mg
`Oral
`netupitant/palonosetron
`(300 mg/0.50 mg) fixed-
`dose combination on
`Day 1 of each cycle.
`Dexamethasone (8 mg)
`will be administered on
`Day 1 of each cycle.
`Drug: NEPA (300mg netupitant/0.5mg
`palonosetron)
`Oral netupitant/palonosetron (300 mg/0.50
`mg) fixed-dose combination on Day 1 of each
`cycle.
`Other Names:
`Akynzeo® capsules
`Drug: Dexamethasone, 8 mg (oral) or equivalent IV
`dose
`Dexamethasone (8 mg) will be administered
`on Day 1 of each cycle.
`Other Names:
`corticosteroid
`Active Comparator:
`Standard of care +
`Dexamethasone 8 mg
`Dexamethasone (or
`equivalent
`corticosteroids) 8 mg
`administered by the oral
`route (or equivalent IV
`dose) on Day 1,
`approximately 1 hour
`before chemotherapy
`and one of the 5-HT3-
`RAs recommended by
`European Society for
`Medical Oncology
`Drug: Granisetron, 2 mg (oral) or 1 mg (IV) OR
`Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR
`Ondansetron, 16 mg (oral) or 8 mg (IV) OR
`Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral
`or IV)
`Standard of care will be administered on Day
`1 of each cycle.
`Other Names:
`5-HT3 RA
`Drug: Dexamethasone, 8 mg (oral) or equivalent IV
`dose
`Dexamethasone (8 mg) will be administered
`on Day 1 of each cycle.
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 9/26
`Page 9 of 26
`
`
`
`
`
`
`
`What is the study measuring?
`Primary Outcome Measures
`(ESMO) and
`Multinational
`Association of
`Supportive Care in
`Cancer (MASCC)
`guidelines (standard of
`care), i.e. either:
`Granisetron, 2 mg (oral)
`or 1 mg (IV) OR
`Palonosetron, 0.5 mg
`(oral), 0.25mg (IV) OR
`Ondansetron, 16 mg
`(oral) or 8 mg (IV) OR
`Dolasetron 100 mg
`(oral) OR Tropisetron 5
`mg (oral or IV)
`Other Names:
`corticosteroid
`Outcome
`Measure Measure Description Time
`Frame
`The proportion
`of complete
`responses over
`three cycles of
`chemotherapy
`after the start
`of the MEC
`administration
`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 a standard of care
`antiemetics over three cycles of chemotherapy.
`At the
`end of
`all three
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 10/26
`Page 10 of 26
`
`
`
`
`
`
`
`Secondary Outcome Measures
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Outcome
`Measure Measure Description Time
`Frame
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 11/26
`Page 11 of 26
`
`
`
`
`
`
`
`Evaluation of
`acute (0 to 24
`hours), delayed
`(>24 to 120
`hours), and
`overall (0-120
`hours) CINV
`indicators in
`each cycle of
`chemotherapy
`Proportion of:
`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
`Time 0 is defined as the start time of the
`chemotherapy administration on Day 1 of each
`of the three cycles.
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`the predictive
`role of potential
`risk factors in
`the
`development of
`CINV over three
`cycles of
`chemotherapy
`Analysis of the development of CINV as a
`dependent variable will be performed to
`identify additional potential risk factors of CINV
`thought to be increasing the risk of CINV in
`patients receiving MEC.
`The outcome measure is the development of
`CINV, defined as any occurrence of nausea or a
`vomiting episode.
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 12/26
`Page 12 of 26
`
`
`
`
`
`
`
`The data on the development of CINV will be
`taken from data collection tools, patients'
`diaries and MASCC Antiemesis Tool (MAT).
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`the safety
`profile of the
`antiemetic drug
`over three
`cycles of
`chemotherapy -
`the frequency
`of adverse
`events (AE)
`An overall summary of adverse events (AE) will
`be presented, including the frequency of
`patients with:
`Any treatment-emergent adverse event
`Any treatment-emergent adverse event
`related to a study drug
`Any treatment-emergent adverse event
`leading to chemotherapy dose reductions
`or interruptions
`Any treatment-emergent serious adverse
`event
`All AEs will be summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 13/26
`Page 13 of 26
`
`
`
`
`
`
`
`Evaluation of
`the safety
`profile of the
`antiemetic drug
`over three
`cycles of
`chemotherapy -
`the percentage
`of adverse
`events (AE)
`An overall summary of adverse events (AE) will
`be presented, including the percentage of
`patients with:
`Any treatment-emergent adverse event
`Any treatment-emergent adverse event
`related to a study drug
`Any treatment-emergent adverse event
`leading to chemotherapy dose reductions
`or interruptions
`Any treatment-emergent serious adverse
`event
`All AEs will be summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`the frequency
`of
`discontinuation
`s due to
`adverse events
`The frequency of discontinuations due to
`adverse events (AE) will be presented.
`All AEs leading to discontinuation will be
`summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 14/26
`Page 14 of 26
`
`
`
`
`
`
`
`range
`from 2
`to 6
`weeks).
`Evaluation of
`the percentage
`of
`discontinuation
`s due to
`adverse events
`The percentage of patients with
`discontinuations due to adverse events (AE)
`will be presented.
`All AEs leading to discontinuation will be
`summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`frequency of on
`treatment
`deaths due to
`adverse events
`The frequency of on treatment deaths due to
`adverse events (AE) will be presented.
`All AEs leading to on treatment deaths will be
`summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 15/26
`Page 15 of 26
`
`
`
`
`
`
`
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`the percentage
`of patients with
`on treatment
`death due to
`adverse events
`The percentage of patients with on treatment
`death due to adverse events (AE) will be
`presented.
`All AEs leading to on treatment death will be
`summarized by their:
`Severity
`Seriousness
`Relationship to a drug
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Listings
`concerning the
`safety profile of
`the antiemetic
`drug over three
`The following listings will be presented:
`All AEs (including pre-treatment AEs)
`Serious adverse events
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 16/26
`Page 16 of 26
`
`
`
`
`
`
`
`cycles of
`chemotherapy
`Adverse events resulting in withdrawn of
`study drug
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Exploration of
`the effect of
`CINV on daily
`activities and
`quality of life in
`patients
`receiving
`moderately-
`emetogenic
`chemotherapy
`over three
`cycles of
`chemotherapy
`Evaluation of the effect of CINV on daily
`activities and quality of life that will be
`measured by using the Functional Living Index-
`Emesis (FLIE) questionnaire, a validated,
`nausea and vomiting specific, patient-reported
`outcome instrument.
`The Functional Living Index-Emesis (FLIE) has
`18 questions. These questions are divided into
`two domains: Nausea (questions 1-9) and
`Vomiting (questions 10-18).
`The minimum score for any question is 0 and
`the maximum score is 100. Higher scores
`indicate less impairment on daily life as a
`result of nausea or vomiting.
`At the
`end of
`all 3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 17/26
`Page 17 of 26
`
`
`
`
`
`
`
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome -
`number of days
`with rescue
`medication
`administered
`for the
`treatment of
`CINV
`Health economic endpoint, the number of days
`with rescue medication administered for the
`treatment of CINV, will be evaluated during the
`study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - daily
`doses of
`rescue
`medication
`administered
`for the
`Health economic endpoint, the daily doses of
`rescue medication administered for the
`treatment of CINV, will be evaluated during the
`study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 18/26
`Page 18 of 26
`
`
`
`
`
`
`
`treatment of
`CINV
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`number of re-
`hydration bags
`Health economic endpoint, the number of re-
`hydration bags given for at least grade 2
`vomiting (more details below), will be evaluated
`during the study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 19/26
`Page 19 of 26
`
`
`
`
`
`
`
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`number of days
`of unplanned
`hospitalisation
`s
`Health economic endpoint, the number of days
`of unplanned hospitalizations related to CINV,
`will be evaluated during the study cycles
`All hospitalizations will be summarized
`according to the department of hospitalization
`(type of ward)
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`number of
`outpatient
`physician visits
`Health economic endpoint, the number of
`outpatient physician visits and health care
`consultations due to CINV (e.g., general
`practitioner), will be evaluated during the study
`cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 20/26
`Page 20 of 26
`
`
`
`
`
`
`
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`number of
`unplanned
`laboratory test
`Health economic endpoint, the number of
`unplanned laboratory test including those at
`unplanned hospitalizations due to CINV, will be
`evaluated during the study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 21/26
`Page 21 of 26
`
`
`
`
`
`
`
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome -
`discontinuation
`of
`chemotherapy
`treatment due
`to CINV
`Health economic endpoint, the number of
`discontinuations of chemotherapy treatment
`due to CINV, will be evaluated during the study
`cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`number of
`delays of
`chemotherapy
`administration
`due to CINV
`Health economic endpoint, the number of
`delays of chemotherapy administration due to
`CINV, will be evaluated during the study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 22/26
`Page 22 of 26
`
`
`
`
`
`
`
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - the
`average length
`of delay of
`chemotherapy
`administration
`due to CINV
`Health economic endpoint, the average length
`of delay (in days) of chemotherapy
`administration due to CINV, will be evaluated
`during the study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 23/26
`Page 23 of 26
`
`
`
`
`
`
`
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Helsinn Healthcare SA
`Evaluation of
`resource
`utilization and
`health
`economic
`outcome - days
`of absence
`from work
`Health economic endpoint, the number of days
`of absence from work, will be evaluated during
`the study cycles
`At the
`end of
`each
`cycle
`and
`after all
`3
`chemot
`herapy
`cycles.
`The
`length
`of a
`cycle
`depend
`s on the
`treatme
`nt being
`given
`(cycles
`range
`from 2
`to 6
`weeks).
`Sponsor
`Investigators
`Study Chair:Alex Molasiotis, prof.,University of Derby
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 24/26
`Page 24 of 26
`
`
`
`
`
`
`
`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 Registration Dates
`First Submitted
`2021-03-01
`First Submitted that Met QC Criteria
`2021-03-24
`First Posted
`2021-03-26
`Study Record Updates
`Last Update Submitted that met QC Criteria
`2024-12-02
`Last Update Posted
`2024-12-04
`Last Verified
`2024-12
`More Information
`Terms related to this study
`HHS Vulnerability Disclosure
`Additional Relevant MeSH Terms
`Signs and Symptoms, Digestive
`Vomiting
`Anti-Inflammatory Agents
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 25/26
`Page 25 of 26
`
`
`
`
`
`
`
`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`Gastrointestinal Agents
`Glucocorticoids
`Hormones
`Hormones, Hormone Substitutes, and Hormone Antagonists
`Antineoplastic Agents, Hormonal
`Antineoplastic Agents
`Antipruritics
`Dermatologic Agents
`Serotonin 5-HT3 Receptor Antagonists
`Serotonin Antagonists
`Serotonin Agents
`Neurotransmitter Agents
`Molecular Mechanisms of Pharmacological Action
`Dexamethasone
`Ondansetron
`Palonosetron
`Granisetron
`Tropisetron
`Dolasetron
`Plan to Share Individual Participant Data (IPD)?
`No
`Studies a U.S. FDA-Regulated Drug Product
`No
`Studies a U.S. FDA-Regulated Device Product
`No
`Product Manufactured in and Exported from the U.S.
`No
`8/3/25, 4:06 PM Study Details | Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) | ClinicalTrials.gov
`https://clinicaltrials.gov/study/NCT04817189 26/26
`Page 26 of 26
`
`
`
`
`
`
`
`