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

Completed · Phase 3

Conditions studied: Chemotherapy-Induced Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT02517021

Run by

Helsinn Healthcare SA

People needed

405

Starts

2015-11-01

Expected to finish

2016-08-01

Last updated by the study team

2018-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• St. Mary's Medical Center — Grand Junction, Colorado, United States
• Well Pharma Medical Research Corporation — Miami, Florida, United States
• Illinois CancerCare — Peoria, Illinois, United States
• Indiana University Health Bloomington — Bloomington, Indiana, United States
• Christus St. Frances Cabrini Hospital — Alexandria, Louisiana, United States
• North Shore Hematology Oncology Associates PC — East Setauket, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• West Cancer Center — Germantown, Tennessee, United States
• Provision Center for Biomedical Research — Knoxville, Tennessee, United States
• University Hospital Graz, Department of Internal Medicine — Graz, Austria
• Krems Country Hospital — Krems, Austria
• Hospital Elisabethinen Linz GmbH, Internal Department #1 - Hemato-Oncology — Linz, Austria
• General Hospital Linz GmbH, Internal Medicine Department #3 - Center for Hematology and Medical Oncology — Linz, Austria
• University Hospital St. Poelten,1st Medical Department — Sankt Pölten, Austria
• Clinical Hospital Centre Osijek — Osijek, Croatia
• General Hospital Varazdin — Varaždin, Croatia
• Clinical Hospital Center "Sestre milosrdnice" — Zagreb, Croatia
• University Hospital Centre Zagreb "Jordanovac" — Zagreb, Croatia
• University Hospital Brno. Clinic of Pulmonary Diseases and Tuberculosis — Brno, Czechia
• University Hospital — Brno, Czechia
• Hospital Novy Jicin, Department of Oncology — Nový Jičín, Czechia
• Thomayer's Hospital, Clinic of Pneumology — Prague, Czechia
• Hospital Na Bulovce — Prague, Czechia
• Sarcoma Oncology Center — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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