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A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

NCT01376297•Helsinn Healthcare SA

View on ClinicalTrials.gov

Summary

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent.
•Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
•Diagnosed with a malignant tumor.
•If scheduled to receive repeated consecutive courses of chemotherapy, a single dose of one or more of the following agents administered on Day 1 is allowed:
•* Highly emetogenic chemotherapy: any I.V. dose of cisplatin, mechlorethamine, streptozocin, cyclophosphamide more or equal to 1500 mg/m2, carmustine, dacarbazine;
•* Moderately emetogenic chemotherapy: any I.V. dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin, cyclophosphamide I.V. (less than 1500 mg/m2), cytarabine I.V. (more than 1 g/m2), azacidine, alemtuzumab, bendamustine, or clofarabine.
•If scheduled to receive combination regimens, the most emetogenic agent is to be given as first on Day 1 and the infusion must be completed within 6 hours.
•If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following the most emetogenic agent or on any subsequent study day.
•ECOG Performance Status of 0, 1, or 2
•Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial
+1 more criteria

Exclusion Criteria

•If female, lactating or pregnant
•Current use of illicit drugs or current evidence of alcohol abuse.
•Scheduled to receive either cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. doxorubicin (more or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (more or equal to 60 mg/m2).
•Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 to Day 5 following Day 1 chemotherapy administration.
•Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient.
•Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or dexamethasone.
•Previously received an NK1 receptor antagonist
•Participation in a clinical trial involving oral netupitant administered in combination with palonosetron.
•Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.
•Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1. Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg of prednisone daily or its equivalent are permitted. Non-study drug dexamethasone as pre-medication in patients scheduled to receive taxanes is allowed.
+9 more criteria

Locations (75)

Northwest Alabama Cancer Center PC

Muscle Shoals, Alabama, United States

East Valley Hematology and Oncology Medical Group

Burbank, California, United States

American Institute of Research

Los Angeles, California, United States

Veterans Administration New Jersey Health Care System

East Orange, New Jersey, United States

Hematology Oncology Associates of Rockland

Nyack, New York, United States

Hematology and Oncology Associates, Inc.

Canton, Ohio, United States

Tri-County Hematology & Oncology Associates, Inc

Massillon, Ohio, United States

Cancer Center at Memorial Hospital of RI

Pawtucket, Rhode Island, United States

Spartanburg Regional Health Services

Spartanburg, South Carolina, United States

South Texas Comrehensive Cancer Centers

Corpus Christi, Texas, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

September 1, 2012

Last Updated

November 17, 2014

Enrollment

413

ACTUAL participants

Conditions

Chemotherapy-Induced Nausea and Vomiting

Interventions

Netupitant and Palonosetron

DRUG

Aprepitant

DRUG

Palonosetron

DRUG

Dexamethasone

DRUG

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

NCT02106494

Chemotherapy-induced Nausea and Vomiting

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COMPLETEDPHASE3

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

NCT01937156

Chemotherapy-induced Nausea and Vomiting

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UNKNOWNPHASE2

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer