Phase 3
N=46
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Malignant Neoplasm · Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT03040726 ↗Enrolled (actual)
46
Serious AEs
5.5%
Results posted
Oct 2023
Primary outcome: Primary: Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15 — -2.0; -2.3 score on a scale — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Netupitant (Drug); Palonosetron (Drug); Palonosetron Hydrochloride (Drug); Placebo (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15 |
-2.0; -2.3 | 0.98 |
| SECONDARY Functional Living Index Emesis (FLIE): Nausea Sub-score |
-16.6; -18 | 0.40 |
| SECONDARY Functional Living Index Emesis (FLIE): Vomiting Sub-score |
-12.5; -9.7 | 0.79 |
| SECONDARY Index of Nausea, Vomiting and Retching: Total Experience Score |
-2.3; -2.5 | 0.57 |
Summary
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.
Eligibility Criteria
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 = 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
Data sourced from ClinicalTrials.gov (NCT03040726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.