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AzTrials

Chemotherapy-induced Nausea and VomitingPhase 4CINVNCT04817189

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

A Phase 4 study testing NEPA (300mg netupitant/0.5mg palonosetron), 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) and Dexamethasone, 8 mg (oral) or equivalent IV dose in people with Chemotherapy-induced Nausea and Vomiting, run by Helsinn Healthcare SA at 19 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
NEPA (300mg netupitant/0.5mg palonosetron), 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) and Dexamethasone, 8 mg (oral) or equivalent IV dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
19 sitesin 7 countries
Study dates
1 Feb 2021to 2 Jul 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

19 sites in 7 countries.

19 sites in 7 countries

Germany5 sites

  • Evang. Kliniken Essen-Mitte

    Essen

  • Universitätsmedizin Mannheim

    Mannheim

  • München Klinik Neuperlach

    München

  • Frauenklinik St. Louise

    Paderborn

  • Klinikum Ernst von Bergmann gemeinnützige GmbH

    Potsdam

Other trials in Germany

Spain4 sites

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, 15006

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 0802

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

China3 sites

  • Shanghai Chest Hospital

    Shanghai

  • Shanghai Ninth People´s Hospital

    Shanghai

  • Shanghai Obstetrics and Gynecology Hospital

    Shanghai

Other trials in China

Czechia2 sites

  • Thomayerova nemocnice

    Prague, 14059

  • General University Hospital in Prague

    Prague

Other trials in Czechia

Greece2 sites

  • Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of Athens

    Athens

  • General University Hospital of Heraklion

    Heraklion

Other trials in Greece

Switzerland2 sites

  • University Hospital Basel

    Basel

  • Swiss Medical Network - Clinique de Genolier

    Genolier

Other trials in Switzerland

United Kingdom1 site

  • The Royal Marsden Hospital

    London

Other trials in United Kingdom

About this study

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

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.

Read more

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:

  1. nausea and/or vomiting in the prior cycle of chemotherapy
  2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy
  3. platinum or anthracycline-based chemotherapy
  4. age < 60 years
  5. expectations for (anticipating) nausea and/or vomiting
  6. <7 h of sleep the night before chemotherapy
  7. history of morning sickness during previous pregnancy
  8. cycle 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.

Read the detailed description

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 vomiting in the prior cycle of chemotherapy
  2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy
  3. platinum or anthracycline-based chemotherapy
  4. age < 60 years
  5. expectations for (anticipating) nausea and/or vomiting
  6. <7 h of sleep the night before chemotherapy
  7. history of morning sickness during previous pregnancy
  8. cycle 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).

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.

Being tested
NEPA (300mg netupitant/0.5mg palonosetron), 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), Dexamethasone, 8 mg (oral) or equivalent IV dose
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEPA (300mg netupitant/0.5mg palonosetron)Drug

    Also called Akynzeo® capsules

    Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.

  • 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

    Also called 5-HT3 RA

    Standard of care will be administered on Day 1 of each cycle.

  • Dexamethasone, 8 mg (oral) or equivalent IV doseDrug

    Also called corticosteroid

    Dexamethasone (8 mg) will be administered on Day 1 of each cycle.

Study groups in NCT04817189
Study groupRoleWhat they receive
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mgExperimentalOral 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.
Receives: Drug: NEPA (300mg netupitant/0.5mg palonosetron); Drug: Dexamethasone, 8 mg (oral) or equivalent IV dose
Standard of care + Dexamethasone 8 mgActive comparatorDexamethasone (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 (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)
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Probability 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.

    The primary endpoint is the probability of complete responses (no emetic episode and no rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three cycles of chemotherapy. This endpoint is evaluated in patients with at least one reported cycle assessment.

    The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.

    Measured: At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

Secondary outcomes (20)

  1. Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy

    Probability of:

    • No emetic episode during the acute, delayed, and overall phase and daily 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.

    The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  2. 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.

    The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  3. 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

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  4. Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events

    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

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  5. Number of Participants With Discontinuations Due to Adverse Events

    The frequency of discontinuations due to adverse events (AE) will be presented.

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  6. Percentage of Participants With Discontinuations Due to Adverse Events

    The percentage of patients with discontinuations due to adverse events (AE) will be presented.

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  7. Number of Participants With Death Due to Adverse Events

    The frequency of on treatment deaths due to adverse events (AE) will be presented.

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  8. Percentage of Participants With 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

    Measured: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  9. 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.

    The model-based statistics of generalized linear model were used to calculate the difference in the score "per cycle" between the treatment arms.

    Measured: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  10. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  11. Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV

    Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  12. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  13. Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations

    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)

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  14. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  15. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  16. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  17. 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.

    Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.

    Measured: At the start of cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  18. 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.

    Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.

    Measured: At the start of Cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  19. 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

    Measured: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

  20. Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy

    Number of vomiting episodes during the acute, delayed, and overall phase in each cycle

    Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles.

    The model-based statistics of generalized linear model were used to calculate the difference in the number of vomiting episodes "per cycle" between the treatment arms.

    Measured: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start1 Feb 2021
  3. Primary completion2 Jul 2024
  4. Study completion2 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
interventional, open label, randomized, active controlled, parallel arms, multicenter and multinational study
Masking
None (open label)
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04817189
Sponsor's protocol ID
IBA1160
Acronym
CINV
Status last verified
Aug 2025
First submitted
1 Mar 2021
Last updated
2 Dec 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NEPA (300mg netupitant/0.5mg palonosetron), 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) and Dexamethasone, 8 mg (oral) or equivalent IV dose in people with Chemotherapy-induced Nausea and Vomiting, run by Helsinn Healthcare SA at 19 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Spain, China, Czechia, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration (time frame: At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04817189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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