NCT03097588

Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant

A Phase II Clinical Trial of NEPA (Netupitant/Palonosetron) for Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patient Receiving the BEAM Conditioning Regimen Prior to Hematopoietic Cell Transplantation (HSCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well netupitant and palonosetron hydrochloride work in preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting caused by the BEAM treatment.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy of netupitant and palonosetron hydrochloride (NEPA) to prevent nausea and vomiting both during and after a highly emetogenic (BEAM) conditioning regimen for hematopoietic stem cell transplantation (HSCT). SECONDARY OBJECTIVES: I. To differentiate response to NEPA over different phases of chemotherapy-induced nausea. OUTLINE: Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride orally (PO) on days 1, 3, and 6. After completion of study treatment, patients are followed up at 14 days.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Netupitant	300 mg, Given PO, QD
DRUG	Palonosetron Hydrochloride	0.5 mg, Given PO, QD
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-04-27
• Primary completion: 2020-02-20
• Completion: 2020-03-20
• First posted: 2017-03-31
• Last updated: 2021-07-12
• Results posted: 2021-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study