Clinical trial · Interventional
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
NCT03040726CI-TRIAL-00070549completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Netupitant | Drug | — | UNRESOLVED |
| Palonosetron | Drug | — | UNRESOLVED |
| Palonosetron Hydrochloride | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (netupitant, palonosetron hydrochloride)
- description
- Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Netupitant
- Drug: Palonosetron
- Drug: Palonosetron Hydrochloride
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Group II (placebo)
- description
- Patients receive placebo PO on days 1, 6, and 11.
- interventionNames
- Other: Placebo
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer * Chronic nausea over the past 4 weeks * Average nausea numeric rating scale \>= 4/10 over the past 5 days at screening * Outpatient at MD Anderson Cancer Center * Karnofsky performance status \>= 50% * Age 18 or older * Able to complete study assessments, including keeping a daily diary Exclusion Criteria: * Delirium (i.e. Memorial Delirium Rating Scale \> 13) * Clinical evidence of bowel obstruction at the time of study enrollment * Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the study * Continuation of over-the-counter therapies for nausea and/or vomiting during the study * On cytotoxic chemotherapy in the high/moderate/low emetogenic risk categories or oral antineoplastic agents in the high or moderate emetogenic risk categories according to the latest National Comprehensive Cancer Network (NCCN) guideline within 2 weeks of study enrollment * On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic glucocorticoids, modafinil, oxcarbazine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone) * On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus) * On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) within one week of study enrollment * Unwilling to provide informed consent * Severe renal impairment (calculated creatinine clearance =\< 29 cc/min) * Calculated creatinine clearance can be done within 14 days of study enrollment * Severe liver impairment (Child-Pugh score \> 9) * Total (T.) bilirubin, albumin, prothrombin time, and serum creatinine tests can be done within 14 days of study enrollment (only if not performed in the last 14 days) * Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control; positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months; pregnancy test to be performed on the day of enrollment; in cases of women with elevated beta-human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a gynecologic examination
References
Publications (1)
- DERIVEDHui D, Puac V, Shelal Z, Liu D, Maddi R, Kaseb A, Javle M, Overman M, Yennurajalingam S, Gallagher C, Bruera E. Fixed-Dose Netupitant and Palonosetron for Chronic Nausea in Cancer Patients: A Double-Blind, Placebo Run-in Pilot Randomized Clinical Trial. J Pain Symptom Manage. 2021 Aug;62(2):223-232.e1. doi: 10.1016/j.jpainsymman.2020.12.023. Epub 2021 Jan 1. PMID 33388382