Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV

NCT03008213 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-12-09

Study results available
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Summary

Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV

Conditions

  • Chemotherapy Induced Nausea Vomiting

Interventions

DRUG

Netupitant and Palonosetron

300 mg of netupitant and 0.5 mg of palonosetron

Sponsors & Collaborators

  • Joseph Ma

    lead OTHER

Principal Investigators

  • Joseph Ma, PharmD · UCSD

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-22
Completion
2018-01-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008213 on ClinicalTrials.gov