Expired Study
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Peoria, Illinois 61615


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.


NCT ID:

NCT02517021


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Peoria, Illinois 61615
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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