Cancer (Solid Tumors)Phase 2NCT07699276
Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin
A Phase 2 study testing dexamethasone sparing in people with Cancer (Solid Tumors) and Vomiting, run by Mahidol University at 1 site in Thailand.
Trial summary
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer (Solid Tumors), Vomiting, Cisplatin
- What is being tested?
- dexamethasone sparing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteThailand
- Study dates
- 10 Feb 2026to 15 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- histologically confirmed solid malignancy
- scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2
Who cannot join
- pregnancy
- pelvic or abdominal radiation within 4 weeks
- uncontrolled brain metastasis
- other moderate or high emetic risk chemotherapy on day 2-5
- untreated gut obstruction
- known allergy or severe adverse effect from palonosetron or olanzapine
- AST/ ALT > 2.5x or serum creatinine clearance less than 50 ml/min
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Suthinee Ithimakin, 0898127440, aesi105@yahoo.co.th
Sirisopa Techawattanawanna, M.D
About this study
Official title: Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
- Conditions
- Cancer (Solid Tumors), Vomiting, Cisplatin, Olanzapine
- Being tested
- dexamethasone sparing
- Keywords
- cisplatin, chemotherapy induced nausea vomiting, dexamethasone sparing, olanzapine
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone sparingDrug
omit dexamethasone on day 2-4
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | olanzapine palonosetron with dexamethasone on day 1 only Receives: Drug: dexamethasone sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
no vomiting and no rescue therapy
Measured: 5 days after receiving chemotherapy
Secondary outcomes (4)
no -nausea rate
no nausea symptom
Measured: 5 days after receiving chemotherapy
degree of nausea vomiting
grading of nausea vomiting
Measured: 5 days after receiving chemotherapy
adverse effects
adverse effects
Measured: 5 days after receiving chemotherapy
rescue therapy
additional treatment for nausea or vomiting
Measured: 5 days after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Feb 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer (Solid Tumors)Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699276
- Sponsor's protocol ID
- 330/2568(IRB4)
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Minatogawa H, Izawa N, Shimomura K, Arioka H, Iihara H, Sugawara M, Morita H, Mochizuki A, Nawata S, Mishima K, Tsuboya A, Miyaji T, Honda K, Yokomizo A, Hashimoto N, Yanagihara T, Endo J, Kawaguchi T, Furuya N, Sone Y, Inada Y, Ohno Y, Katada C, Hida N, Akiyama K, Ichikura D, Konomatsu A, Ogura T, Yamaguchi T, Nakajima TE. Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial). Br J Cancer. 2024 Feb;130(2):224-232. doi: 10.1038/s41416-023-02493-7. Epub 2023 Nov 16.
PubMed 37973958Ithimakin S, Theeratrakul P, Laocharoenkiat A, Nimmannit A, Akewanlop C, Soparattanapaisarn N, Techawattanawanna S, Korphaisarn K, Danchaivijitr P. Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy. Support Care Cancer. 2020 Nov;28(11):5335-5342. doi: 10.1007/s00520-020-05380-6. Epub 2020 Mar 4.
PubMed 32128615Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
PubMed 35999527Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study. Oncologist. 2021 Oct;26(10):e1854-e1861. doi: 10.1002/onco.13851. Epub 2021 Jun 18.
PubMed 34101934
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT07699276
- Acronym / sponsor ID
- 330/2568(IRB4)
- Conditions
- Cancer (Solid Tumors), Vomiting, Cisplatin, Olanzapine
- Keywords
- cisplatin, chemotherapy induced nausea vomiting, dexamethasone sparing, olanzapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: dexamethasone sparingolanzapine palonosetron with dexamethasone on day 1 only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- histologically confirmed solid malignancy
- scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2
Key exclusion criteria (7 listed)
- pregnancy
- pelvic or abdominal radiation within 4 weeks
- uncontrolled brain metastasis
- other moderate or high emetic risk chemotherapy on day 2-5
- untreated gut obstruction
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 |
|---|---|---|
| dexamethasone sparingomit dexamethasone on day 2-4 | Drug | study arm |
Primary outcome
complete response rate
Time frame: 5 days after receiving chemotherapy
no vomiting and no rescue therapy
4 secondary outcomes
no -nausea rate
Time frame: 5 days after receiving chemotherapy
degree of nausea vomiting
Time frame: 5 days after receiving chemotherapy
adverse effects
Time frame: 5 days after receiving chemotherapy
rescue therapy
Time frame: 5 days after chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 37973958Minatogawa H, Izawa N, Shimomura K, Arioka H, Iihara H, Sugawara M, Morita H, Mochizuki A, Nawata S, Mishima K, Tsuboya A, Miyaji T, Honda K, Yokomizo A, Hashimoto N, Yanagihara T, Endo J, Kawaguchi T, Furuya N, Sone Y, Inada Y, Ohno Y, Katada C, Hida N, Akiyama K, Ichikura D, Konomatsu A, Ogura T, Yamaguchi T, Nakajima TE. Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial). Br J Cancer. 2024 Feb;130(2):224-232. doi: 10.1038/s41416-023-02493-7. Epub 2023 Nov 16.
- Background: PubMed 32128615Ithimakin S, Theeratrakul P, Laocharoenkiat A, Nimmannit A, Akewanlop C, Soparattanapaisarn N, Techawattanawanna S, Korphaisarn K, Danchaivijitr P. Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy. Support Care Cancer. 2020 Nov;28(11):5335-5342. doi: 10.1007/s00520-020-05380-6. Epub 2020 Mar 4.
- Background: PubMed 35999527Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
- Background: PubMed 34101934Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study. Oncologist. 2021 Oct;26(10):e1854-e1861. doi: 10.1002/onco.13851. Epub 2021 Jun 18.
- Individual participant dataSharing planned: Undecided
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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.
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 dexamethasone sparing in people with Cancer (Solid Tumors) and Vomiting, run by Mahidol University at 1 site 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suthinee Ithimakin (+66898127440, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (time frame: 5 days after receiving 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 NCT07699276, which also lists 4 linked publications.
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 13 Jul 2026.