Steroid-Sparing Plan with Olanzapine and Palonosetron to Prevent Nausea in High-Dose Cisplatin
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
Run by Mahidol University · NCT07699276 · Data updated 2026-11-12
This phase II trial tests a steroid-sparing regimen using olanzapine and palonosetron to prevent chemotherapy-induced nausea and vomiting in patients getting high-dose cisplatin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 95 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bangkok) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | November 15, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07699276 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with solid tumors starting high-dose cisplatin (≥50 mg/m2) who can take olanzapine and palonosetron and do not have contraindications to these drugs.
✕Probably not a fit
Patients with uncontrolled brain metastases, recent pelvic/abdominal radiation, other high-emetogenic regimens on days 2-5, or significant liver/kidney impairment may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a dexamethasone-sparing approach for preventing nausea and vomiting in cancer patients receiving high-dose cisplatin. Olanzapine and palonosetron are used as the antiemetic backbone, with cisplatin as the emetogenic driver. Eligible participants have a histologically confirmed solid tumor and are starting their first cisplatin cycle at 50 mg/m2 or higher. The trial aims to determine whether this regimen can provide effective control of emesis while reducing steroid exposure. Safety and tolerability will be monitored, including potential allergic reactions and liver or kidney function concerns.
Why it matters
Potential benefit: If successful, patients may experience better control of chemotherapy-induced nausea and vomiting with fewer steroids.
How similar studies have gone: There is prior evidence supporting olanzapine-based regimens for antiemesis in cisplatin, but this specific steroid-sparing combination is being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed solid malignancy * scheduled for first cycle of cisplatin at dosage of at least 50 mg/m2 Exclusion Criteria: * 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
Where it's running
-
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Suthinee Ithimakin
- Email: aesi105@yahoo.co.th
- Phone: +66898127440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.