Chemotherapy Induced Nausea and VomitingPhase 2NCT06065722
Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy
A Phase 2 study testing Akynzeo in people with Chemotherapy Induced Nausea and Vomiting, run by Simon Williamson Clinic at 1 site in United States.
Trial summary
The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Induced Nausea and Vomiting
- What is being tested?
- Akynzeo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2023to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CHEMOTHERAPY NAIIVE
- patient receiving moderately or highly emetogenic chemotherapy
- lung cancer
- breast cancer
Who cannot join
- PRIOR CHEMOTHERAPY for any cancer
- nausea or vomiting 24 hours prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rudolph M Navari
Mount Olive, Alabama, 35117
Rudolph M Navari, 574-261-8385, rmnavari@gmail.com
Rudolph M Navari, 5742618385, rmnavari@gmail.com
About this study
Official title: Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines
Read the detailed description
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV.
Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor Factors Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History of prior low chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous chemotherapy-induced emesis
Significant and uncontrolled CINV may result in patients returning to the chemotherapy treatment facility one to three days post-chemotherapy for rehydration, or emesis or nausea control. If CINV cannot be controlled in an outpatient facility, patients may subsequently be treated in an emergency department or require hospitalization. Patients who have an electrolyte imbalance or those who have recently undergone surgery or radiation therapy, are at greater risk of experiencing serious complications from CINV.
The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of CINV Additional improvement in the control of CINV has occurred with the use of neurokinin-1 (NK-1) receptor antagonists, and olanzapine, an antipsychotic which blocks multiple neurotransmitters in the central nervous system.
The primary endpoint used for studies evaluating various agents for the control of CINV has been complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours post-chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The combination of a 5-HT3 receptor antagonist, dexamethasone, and a NK-1 receptor antagonist have improved the control of emesis in patients receiving either highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) over a 120-hour period following chemotherapy administration
The use of effective antiemetic agents in various clinical settings has been described in established guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO)], and the National Comprehensive Cancer Network (NCCN).
The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2 of MEC or HEC for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines.
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Being tested
- Akynzeo
- Keywords
- chemotherapy induced nausea and vomiting, NK-1, olanzapine
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AkynzeoDrug
Also called Olanzapine
OLANZAPINE
| Study group | Role | What they receive |
|---|---|---|
| AKYNZEO for patient receiving MEC | Active comparator | Add Akynzeo to 5HT3 And dexamethasone Receives: Drug: Akynzeo |
| oLANZAPINE and Akynzeo to patients receiving highly emetogenic | Active comparator | olANZAPINE plus Akynzeo Receives: Drug: Akynzeo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPELETE RESPONSE, no vomiting or use of rescue medications
No vomiting or use of rescue medications for 5 days post chemotherapy
Measured: 5 DAYS post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start9 Sep 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Williamson Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helsinn Healthcare SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065722
- Sponsor's protocol ID
- SWC999
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Navari RM, Bonizzoni E. NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial. Cancer Med. 2025 Apr;14(7):e70549. doi: 10.1002/cam4.70549.
PubMed 40145359
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
- ClinicalTrials.gov ID
- NCT06065722
- Acronym / sponsor ID
- SWC999
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Keywords
- chemotherapy induced nausea and vomiting, NK-1, olanzapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Simon Williamson ClinicIndustry (pharma, biotech, devices)
- Collaborators
- Helsinn Healthcare SA
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines
Detailed description
Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV.
Table 1. Patient-Related Risk Factors for Emesis Following Chemotherapy Major Factors Minor Factors Female History of Motion Sickness Age < 50 years Emesis during past pregnancy History of prior low chronic alcohol intake (<1 ounce of alcohol/day) Anxiety History of previous chemotherapy-induced emesis
Significant and uncontrolled CINV may result in patients returning to the chemotherapy treatment facility one to three days post-chemotherapy for rehydration, or emesis or nausea control. If CINV cannot be controlled in an outpatient facility, patients may subsequently be treated in an emergency department or require hospitalization. Patients who have an electrolyte imbalance or those who have recently undergone surgery or radiation therapy, are at greater risk of experiencing serious complications from CINV.
The use of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists has improved the control of CINV Additional improvement in the control of CINV has occurred with the use of neurokinin-1 (NK-1) receptor antagonists, and olanzapine, an antipsychotic which blocks multiple neurotransmitters in the central nervous system.
The primary endpoint used for studies evaluating various agents for the control of CINV has been complete response (CR) (no emesis, no use of rescue medication) over the acute (24 hours post-chemotherapy), delayed (24-120 hours), and overall (0-120 hours) periods. The combination of a 5-HT3 receptor antagonist, dexamethasone, and a NK-1 receptor antagonist have improved the control of emesis in patients receiving either highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) over a 120-hour period following chemotherapy administration
The use of effective antiemetic agents in various clinical settings has been described in established guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO)], and the National Comprehensive Cancer Network (NCCN).
The purpose of the proposed is to provide a clinical approach to CINV prophylaxis in cycle 2 of MEC or HEC for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKYNZEO for patient receiving MEC | Active comparator | Drug: AkynzeoAdd Akynzeo to 5HT3 And dexamethasone |
| oLANZAPINE and Akynzeo to patients receiving highly emetogenic | Active comparator | Drug: AkynzeoolANZAPINE plus Akynzeo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CHEMOTHERAPY NAIIVE
- patient receiving moderately or highly emetogenic chemotherapy
- lung cancer
- breast cancer
Key exclusion criteria (2 listed)
- PRIOR CHEMOTHERAPY for any cancer
- nausea or vomiting 24 hours prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AkynzeoAlso: OlanzapineOLANZAPINE | Drug | AKYNZEO for patient receiving MEC, oLANZAPINE and Akynzeo to patients receiving highly emetogenic |
Primary outcome
COMPELETE RESPONSE, no vomiting or use of rescue medications
Time frame: 5 DAYS post chemotherapy
No vomiting or use of rescue medications for 5 days post chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40145359Navari RM, Bonizzoni E. NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial. Cancer Med. 2025 Apr;14(7):e70549. doi: 10.1002/cam4.70549.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Akynzeo in people with Chemotherapy Induced Nausea and Vomiting, run by Simon Williamson Clinic at 1 site in United States.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rudolph M Navari (5742618385, rmnavari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPELETE RESPONSE, no vomiting or use of rescue medications (time frame: 5 DAYS post chemotherapy). 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 NCT06065722, which also lists 1 linked publication.
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 10 Oct 2023.