Antiemetic for Highly Emetogenic ChemotherapyPhase 3NCT03876938
Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy
A Phase 3 study testing aprepitant, olanzapine 10 mg and olanzapine 5 mg in people with Antiemetic for Highly Emetogenic Chemotherapy, run by Mahidol University at 2 sites in Thailand.
Trial summary
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiemetic for Highly Emetogenic Chemotherapy
- What is being tested?
- aprepitant, olanzapine 10 mg and olanzapine 5 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Mar 2019to Dec 2020
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically proved of solid malignancy
- receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin
Who cannot join
- pregnancy
- patients with episode of vomiting within 24 hours before starting chemotherapy
- uncontrolled brain/ CNS metastasis
- gut obstruction
- receive combination of moderate or high emetogenic chemotherapy during Day 2-5
- Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
- currently receive olanzapine with other indication and plan to continue the drug
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, 10700
Suthinee Ithimakin, MD, 662-419-4489, aesi105@yahoo.co.th
Suthinee Ithimakin, MD
- Recruiting
Siriraj Hospital
Bangkok, 10700
Suthinee Ithimakin, MD
About this study
Official title: Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.
Read the detailed description
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.
- Being tested
- aprepitant, olanzapine 10 mg, olanzapine 5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
olanzapine 10 mgDrug
olanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
olanzapine 5 mgDrug
olanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
| Study group | Role | What they receive |
|---|---|---|
| aprepitant | Active comparator | aprepitant / dexamethasone/ ondansetron Receives: Drug: aprepitant |
| olanzapine 10 mg | Experimental | olanzapine 10 mg/dexamethasone/ ondansetron Receives: Drug: olanzapine 10 mg |
| olanzapine 5 mg | Experimental | olanzapine 5 mg/dexamethasone/ ondansetron Receives: Drug: olanzapine 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
no nausea rate
proportion of patients report no nausea
Measured: Days 1-5 of chemotherapy
Secondary outcomes (2)
complete remission
no episode of vomiting
Measured: Days 1-5 of chemotherapy
>= grade 3 vomiting
higher than grade 3 vomiting
Measured: Days 1-5 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Mar 2019
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiemetic for Highly Emetogenic ChemotherapyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suthinee Ithimakin, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876938
- Sponsor's protocol ID
- 728/2561(EC4)
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Trial of Olanzapine Versus Aprepitant Plus Ondansetron and Dexamethasone as Antiemetic Prophylaxis in Patients Receiving High Emetic Chemotherapy
- ClinicalTrials.gov ID
- NCT03876938
- Acronym / sponsor ID
- 728/2561(EC4)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Mar 2019 (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.
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.
Detailed description
Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aprepitant | Active comparator | Drug: aprepitantaprepitant / dexamethasone/ ondansetron |
| olanzapine 10 mg | Experimental | Drug: olanzapine 10 mgolanzapine 10 mg/dexamethasone/ ondansetron |
| olanzapine 5 mg | Experimental | Drug: olanzapine 5 mgolanzapine 5 mg/dexamethasone/ ondansetron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pathologically proved of solid malignancy
- receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin
Key exclusion criteria (7 listed)
- pregnancy
- patients with episode of vomiting within 24 hours before starting chemotherapy
- uncontrolled brain/ CNS metastasis
- gut obstruction
- receive combination of moderate or high emetogenic chemotherapy during Day 2-5
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 |
|---|---|---|
| aprepitantaprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4 | Drug | aprepitant |
| olanzapine 10 mgolanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4 | Drug | olanzapine 10 mg |
| olanzapine 5 mgolanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4 | Drug | olanzapine 5 mg |
Primary outcome
no nausea rate
Time frame: Days 1-5 of chemotherapy
proportion of patients report no nausea
2 secondary outcomes
complete remission
Time frame: Days 1-5 of chemotherapy
>= grade 3 vomiting
Time frame: Days 1-5 of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- 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.
Suthinee Ithimakin, MD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aprepitant, olanzapine 10 mg and olanzapine 5 mg in people with Antiemetic for Highly Emetogenic Chemotherapy, run by Mahidol University at 2 sites in Thailand.
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 2 inclusion and 7 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Suthinee Ithimakin, MD (+6624194489, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no nausea rate (time frame: Days 1-5 of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2019.