Netupitant and Palonosetron (AKYNZEO) for Chronic Nausea and Vomiting in Cancer Patients

Inclusion Criteria:

1. Diagnosis of cancer

2. Chronic nausea over the past 4 weeks

3. Average nausea numeric rating scale >/=4/10 over the past 5 days at screening

4. Outpatient at MD Anderson Cancer Center

5. Karnofsky performance status >/=50%

6. Age 18 or older

7. Able to complete study assessments, including keeping a daily diary

Exclusion Criteria:

1. Delirium (i.e. Memorial Delirium Rating Scale >13)

2. Clinical evidence of bowel obstruction at the time of study enrollment

3. Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the
study

4. Continuation of over-the-counter therapies for nausea and/or vomiting during the study

5. 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 NCCN guideline within 2 weeks of study enrollment

6. On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe,
carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic
glucocorticoids, modafinil, oxcarbazepine, phenobarbital, pioglitazone, rifabutin, St.
John's wort, troglitazone)

7. On scheduled CYP3A4 substrates with narrow safety range at the time of study
enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide,
quinidine, sirolimus, tacrolimus)

8. 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

9. Unwilling to provide informed consent

10. Severe renal impairment (calculated Creatinine clearance <=29 cc/min)

11. Severe liver impairment (Child-Pugh Score >9)

12. 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 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.