NCT07699276

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
15mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Nov 2027

Study Start

First participant enrolled

February 10, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Cancer (Solid Tumors)VomitingCisplatinOlanzapine

Keywords

cisplatinchemotherapy induced nausea vomitingdexamethasone sparingolanzapine

Outcome Measures

Primary Outcomes (1)

  • complete response rate

    no vomiting and no rescue therapy

    5 days after receiving chemotherapy

Secondary Outcomes (4)

  • no -nausea rate

    5 days after receiving chemotherapy

  • degree of nausea vomiting

    5 days after receiving chemotherapy

  • adverse effects

    5 days after receiving chemotherapy

  • rescue therapy

    5 days after chemotherapy

Study Arms (1)

study arm

EXPERIMENTAL

olanzapine palonosetron with dexamethasone on day 1 only

Drug: dexamethasone sparing

Interventions

dexamethasone sparingDRUG

omit dexamethasone on day 2-4

study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (4)

  • 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.

    PMID: 37973958BACKGROUND

  • 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.

    PMID: 32128615BACKGROUND

  • 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.

    PMID: 35999527BACKGROUND

  • 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.

    PMID: 34101934BACKGROUND

MeSH Terms

Conditions

NeoplasmsVomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Suthinee Ithimakin

CONTACT

+66898127440aesi105@yahoo.co.th

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 15, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

TH(1)