ClinicalTrials.gg
RecruitingNCT07699276Updated Jul 13, 2026

Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin

A Phase 2 interventional study of dexamethasone sparing in Cancer (Solid Tumors), Vomiting and Cisplatin, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Mahidol University · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2026, registered Jul 2026).
  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Cancer (Solid Tumors)
  • Vomiting
  • Cisplatin
  • Olanzapine

Keywords

  • cisplatin
  • chemotherapy induced nausea vomiting
  • dexamethasone sparing
  • olanzapine
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 95 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed solid
  • scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • pelvic or abdominal radiation within 4 weeks
  • uncontrolled
  • other moderate or high emetic risk chemotherapy on day 2-5
  • untreated gut obstruction
  • known allergy or severe adverse effect from palonosetron or olanzapine
  • / ALT > 2.5x or serum less than 50 ml/min
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (estimated)

Study arms

  • Experimental
    study arm

    olanzapine palonosetron with dexamethasone on day 1 only

    Drug: dexamethasone sparing

Interventions

  • Drugdexamethasone sparing

    omit dexamethasone on day 2-4

06

What researchers measure

Primary outcomes

  1. complete response rate

    no vomiting and no rescue therapy

    Time frame: 5 days after receiving chemotherapy

Secondary outcomes

  1. no -nausea rate

    no nausea symptom

    Time frame: 5 days after receiving chemotherapy

  2. degree of nausea vomiting

    grading of nausea vomiting

    Time frame: 5 days after receiving chemotherapy

  3. adverse effects

    adverse effects

    Time frame: 5 days after receiving chemotherapy

  4. rescue therapy

    additional treatment for nausea or vomiting

    Time frame: 5 days after chemotherapy

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
    Recruiting
    • Suthinee Ithimakin · Contactaesi105@yahoo.co.th · 0898127440
    • Sirisopa Techawattanawanna, M.D · Principal investigator
    • Akarin Nimmannit, M.D · Sub investigator
    • Visullaya Sa-nguanwongwan, M.D · Sub investigator
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References and documents

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 37973958 ↗
  • Ithimakin 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 32128615 ↗
  • Celio 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 35999527 ↗
  • Celio 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Oct 2027, 19 months after the start.

Of 335 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 99. This study's planned 19 months is below that.

Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 13, 2026
StartActual
Feb 10, 2026
Primary completionEst.
Oct 1, 2027
CompletionEst.
Nov 15, 2027
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07699276
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
Feb 10, 2026
Primary completion
Oct 1, 2027 (estimated)
Completion
Nov 15, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Suthinee Ithimakin
Contact
aesi105@yahoo.co.th
+66898127440

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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