Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Helsinn Healthcare SA; National Cancer Institute (NCI)
• Treatments: Palonosetron

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 =< 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