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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-03

Study Completion Date

2022-02-14

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate the efficacy (i.e. change in nausea numeric rating scale \[NRS\] from baseline between day 5-15) of fixed dose netupitant and palonosetron hydrochloride (palonosetron) (NEPA) for chronic nausea in cancer patients.

SECONDARY OBJECTIVES:

I. To assess the secondary outcomes (e.g. proportion of patients who achieved their personalized nausea goal, antiemetic use, nausea episodes duration/frequency) for NEPA versus (vs.) placebo.

II. To assess the adverse effects associated with NEPA and placebo.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive placebo PO on days 1, 6, and 11.

Conditions

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Malignant Neoplasm Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I (netupitant, palonosetron hydrochloride)

Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Netupitant

Intervention Type DRUG

Given PO

Palonosetron

Intervention Type DRUG

Given PO

Palonosetron Hydrochloride

Intervention Type DRUG

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (placebo)

Patients receive placebo PO on days 1, 6, and 11.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Netupitant

Given PO

Intervention Type DRUG

Palonosetron

Given PO

Intervention Type DRUG

Palonosetron Hydrochloride

Given PO

Intervention Type DRUG

Placebo

Given PO

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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CID6451149 D05152 RO 67-3189/000 Aloxi RS 25259-197 placebo therapy PLCB sham therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No