East Setauket, New York 11733

  • Induced Nausea and Vomiting

Purpose:

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.


Criteria:

Inclusion Criteria: Cycle 1 - Signed written informed consent - Histologically or cytologically confirmed solid tumor malignancy. - Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted. - Scheduled to receive at least 4 repeated consecutive cycles of the following highly emetogenic reference chemotherapies (HEC), alone or in combination with other chemotherapeutic agents on Day 1: cisplatin administered as a single IV dose of ≥ 70 mg/m2; cyclophosphamide ≥1500 mg/m2; carmustine (BCNU) >250mg/m2; dacarbazine (DTIC); mechloretamine (nitrogen mustard) - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 . - If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test. - Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance) - Able to read, understand, follow the study procedure and complete patient diary. Cycles 2 to 4: The following inclusion criteria must be checked prior to inclusion at each repeated cycle: - Participation in the study during the next cycle of chemotherapy is considered appropriate by the Investigator and does not pose unwarranted risk to the patient. - Scheduled to receive the same chemotherapy regimen as Cycle 1 or one of the reference chemotherapies as defined in Inclusion criterion 5 for Cycle 1. - If a patient is female, she shall be of non--childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test. - Adequate hematologic and metabolic status according to the Investigator's opinion. Exclusion Criteria: Cycle 1 - Lactating woman. - Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient. - Current use of illicit drugs or current evidence of alcohol abuse. - Scheduled to receive moderately or highly emetogenic chemotherapies from Day 2 to Day 5. - Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference chemotherapy administration on Day 1 or between Days 1 to 5. - Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference chemotherapy administration on Day 1. - Symptomatic primary or metastatic CNS malignancy. - Known hypersensitivity or contraindication to 5-HT3 receptor antagonists, to dexamethasone or to NK-1 receptor antagonists. - Known contraindication to the IV administration of 50 mL 5% glucose solution. - Previously received an NK-1 receptor antagonist. - Participation in a previous clinical trial involving IV pro-netupitant or oral netupitant administered alone or in combination with palonosetron. - Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the present study. - Systemic corticosteroid therapy at any dose within 72 hours prior to the start of reference chemotherapy administration on Day 1. Topical and inhaled corticosteroids are permitted. - Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy. - Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within 1 week prior to Day 1. - Scheduled to receive any of the following CYP3A4 substrates within 1 week prior to Day 1: terfenadine, cisapride, astemizole, pimozide. - Received within 4 weeks prior to Day 1 or scheduled to receive any CYP3A4 inducer. - Any medication with known or potential antiemetic activity within 24 hours prior to the start of reference chemotherapy administration on Day 1 of Cycle 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists - History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block - History of Torsade de Point or known history of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome). - Severe cardiovascular diseases diagnosed within 3 months prior to Day 1 of first cycle, including myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension. - Any illness or condition that, in the opinion of the Investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. - Concurrent medical condition that would preclude administration of dexamethasone such as systemic fungal infection or uncontrolled diabetes. Cycles 2 to 4: The following exclusion criteria must be checked prior to inclusion in each repeated cycle: - Lactating woman. - Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient. - Started any of the restricted medications. - Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of reference chemotherapy administration on Day 1. - Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference chemotherapy administration on Day 1 or between Days 1 to 5. - Symptomatic primary or metastatic CNS malignancy.


Study is Available At:


Original ID:

NEPA-15-18


NCT ID:

NCT02517021


Secondary ID:


Study Acronym:


Brief Title:

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting


Official Title:

A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemothera


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Helsinn Healthcare SA


Oversight Authority:

  • United States: Food and Drug Administration
  • Austria: Austrian Federal Office for Safety in Health Care
  • Czech Republic: State Institute for Drug Control
  • Germany: Federal Institute for Drugs and Medical Devices
  • Italy: The Italian Medicines Agency
  • Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • South Africa: Medicines Control Council
  • Spain: Spanish Agency of Medicines
  • Ukraine: State Pharmacological Center - Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

405


Enrollment Type:

Actual


Study Dates

Start Date:November 2015
Completion Date:August 2016
Completion Type:Actual
Primary Completion Date:August 2016
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 18, 2018
First Received Date:August 3, 2015
First Results Date:May 9, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of Patients With Adverse Events
Time Frame:Participants will be followed for the duration of the chemotherapy, an expected average duration of
Safety Issues:False
Description:This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the pres
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
Time Frame:0-24 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
Time Frame:>24-120 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
Time Frame:0-120 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Emetic Episodes in the Acute Phase
Time Frame:0-24 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Emetic Episodes in the Delayed Phase
Time Frame:>24-120 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Emetic Episodes in the Overall Phase
Time Frame:0-120 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase
Time Frame:0-24 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase
Time Frame:>24-120 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase
Time Frame:0-120 hours
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pro-netupitant/Palonosetron
Arm Name:Pro-netupitant/Palonosetron plus Dexamethasone
Other Name:IV NEPA FDC
Intervention Type:Drug
Name:Netupitant/Palonosetron
Arm Name:Netupitant/Palonosetron plus Dexamethasone
Other Name:Oral NEPA FDC
Intervention Type:Drug
Name:Dexamethasone
Arm Name:Pro-netupitant/Palonosetron plus Dexamethasone

Study Arms

Study Arm Type:Experimental
Arm Name:Pro-netupitant/Palonosetron plus Dexamethasone
Description:Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Study Arm Type:Active Comparator
Arm Name:Netupitant/Palonosetron plus Dexamethasone
Description:Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Helsinn Healthcare SA
Agency Class:Other
Agency Type:Collaborator
Agency Name:PSI CRO AG

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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