NCT03040726

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Malignant Neoplasm
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Netupitant	Given PO
DRUG	Palonosetron	Given PO
DRUG	Palonosetron Hydrochloride	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-05-03
• Primary completion: 2022-02-14
• Completion: 2022-02-14
• First posted: 2017-02-02
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study