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
NCT ID: NCT03403712
Last Updated: 2020-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
404 participants
INTERVENTIONAL
2018-03-16
2018-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Test group
intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle.
Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
fosnetupitant/ palonosetron
intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
dexamethasone
Oral dexamethasone (12 mg)
Control group
oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
netupitant/palonosetron
oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
dexamethasone
Oral dexamethasone (12 mg)
Interventions
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fosnetupitant/ palonosetron
intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
netupitant/palonosetron
oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
dexamethasone
Oral dexamethasone (12 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patient read, understood and signed the written informed consent before any study related activity, agreeing to participate in the study and to comply with study requirements.
2. Female patient of at least 8 years of age.
3. Histologically or cytologically confirmed breast cancer, including recurrent or metastatic.
4. Naïve to moderately or highly emetogenic antineoplastic agents.
5. Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.
Notes:
1. additional not emetogenic, minimally or low emetogenic antineoplastic agents are permitted at any time after start of AC combination on Day 1.
2. additional highly or moderately emetogenic antineoplastic agents are only allowed on Day 1 after the start of AC combination, provided their administration is completed within 6 hours from the start of the AC combination administration.
6. ECOG Performance Status of 0 or 1.
7. Patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to dose of investigational product.
Notes:
1. Female patients of non-childberaring potential are defined as being in post-menopausal state since at least 1 year; or having documented surgical sterilization or hysterectomy at least 3 months before study participation.
2. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence;
8. Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy based on investigator's assessment.
9. If the patient has a known hepatic or renal impairment, she may be enrolled in the study at the discretion of the Investigator.
10. Able to read, understand, follow the study procedure and complete the patient diary.
Cycles 2 to 4:
1. 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.
2. Scheduled to receive an AC chemotherapy regimen or AC chemotherapy together with other chemotherapies as defined in Inclusion criterion #5 for Cycle 1.
3. Patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to dosing of investigational product.
4. Adequate hematologic and metabolic status for receiving a cycle of AC chemotherapy according to the Investigator's opinion.
Exclusion Criteria
1. Lactating patient.
2. Current use of illicit drugs or current evidence of alcohol abuse.
3. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 and up to Day 1 of Cycle 2.
4. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of AC chemotherapy administration on Day 1 or between Days 1 to 5, inclusive.
5. Any vomiting, retching, or nausea (grade 1 as defined by National Cancer Institute) within 24 hours prior to the start of AC chemotherapy administration on Day 1.
6. Symptomatic primary or metastatic central nervous system (CNS) malignancy.
7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting \[CINV\]) or pose unwarranted risks in administering the study drugs to the patient.
8. Known hypersensitivity or contraindication to 5 hydroxytryptamine type 3 (5-HT3) receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron), to dexamethasone, or to neurokinin-1 (NK1) receptor antagonists (e.g., aprepitant, rolapitant).
9. Known contraindication to the IV administration of 50 mL 5% glucose solution.
10. Participation in a previous clinical trial involving IV fosnetupitant or oral netupitant administered alone or in combination with palonosetron.
11. Any investigational drugs taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug (other than those planned by the study protocol) during the present study.
12. Systemic corticosteroid therapy within 72 hours prior to the start of AC chemotherapy administration on Day 1, except the dexamethasone provided as additional study drug. However, topical and inhaled corticosteroids are permitted.
13. Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy during the study participation.
14. Other than as administered as part of the study protocol, any medication with known or potential antiemetic activity within 24 hours prior to the start of AC chemotherapy administration on Day 1, including:
* 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron, palonosetron)
* NK1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant or any other new drug of this class)
* benzamides (e.g., metoclopramide, alizapride)
* phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine)
* benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1).
* butyrophenones (e.g., haloperidol, droperidol)
* anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for respiratory disorders, e.g., ipratropium bromide)
* antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorpheniramine)
* domperidone
* mirtazapine
* olanzapine
* prescribed cannabinoids (e.g., tetrahydrocannabinol or nabilone)
* Over The Counter (OTC) antiemetics, OTC cold or OTC allergy medications.
15. Scheduled to receive any strong or moderate inhibitor of CYP3A4 during the efficacy assessment period (Day 1 to Day 5, inclusive) or its intake within 1 week prior to Day 1.
16. Scheduled to receive any CYP3A4 inducer during the efficacy assessment period (Day 1 to Day 5, inclusive) or its intake within 4 weeks prior to Day 1, with the exception of corticosteroids (for which exclusion criterion #12 applies).
17. History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block.
18. History of risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of Long QT Syndrome).
19. Severe or uncontrolled cardiovascular diseases, including myocardial infarction within 3 months prior to Day 1, 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.
Cycles 2 to 4:
1. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 of current cycle and up to Day 1 of the next cycle.
2. Active infection or uncontrolled disease that may pose unwarranted risks in administering the study drugs to the patient.
3. Started any of the prohibited medications.
4. Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of AC chemotherapy administration on Day 1.
5. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of AC chemotherapy administration on Day 1 or between Days 1 to 5.
6. Symptomatic primary or metastatic CNS malignancy.
7. Any illness or medical condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product or dexamethasone to the patient.
18 Years
FEMALE
No
Sponsors
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Emerald Clinical Inc.
INDUSTRY
The Physicians' Services Incorporated Foundation
OTHER
Helsinn Healthcare SA
INDUSTRY
Responsible Party
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Locations
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The Oncology Inst. Of Hope and Innovation
Tucson, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
CBCC Global Research, INC at Comprehensive Blood and Cancer Center
Bakersfield, California, United States
The Oncology Tnstitute of Hope and Innovation
Corona, California, United States
Uptimum Medical Group Inc.
Inglewood, California, United States
The Oncology Institute of Hope and Innnovation
Long Beach, California, United States
Hao Wei Zhang M.D.
Los Angeles, California, United States
Emad Ibrahim, MD, INC.
Redlands, California, United States
Watson Clinic LLP
Lakeland, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Cancer Center of !\!Iiddle Georgia
Dublin, Georgia, United States
Harbin Clinic
Rome, Georgia, United States
Summit Cancer Care
Savannah, Georgia, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Presence Infusion Care - Skokie
Skokie, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
TU Health Arnett Cancer Center
Lafayette, Indiana, United States
Baptist Health Cancer Center
New Albany, Indiana, United States
Cotton O'Neil Clinical Res. Ctr., Hematology & Oncology
Topeka, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
CHRISTUS Cancer Treatment Center
Shreveport, Louisiana, United States
Mercy Medical Center, Medical Oncology and Hematology
Baltimore, Maryland, United States
Hattiesburg Clinic Hematology Oncology
Hattiesburg, Mississippi, United States
Cornell-Beshore Cancer Institute
Joplin, Missouri, United States
Cox Mcdical ·Centers
Springfield, Missouri, United States
Trinitas Cancer Center
Elizabeth, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Mid Ohio Oncology/Hematology Inc. DBA The Mark H. Zangmeister Center
Columbus, Ohio, United States
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States
Carolina Blood and Cancer Care Associates, P.A.
Rock Hill, South Carolina, United States
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, United States
Cheyenne Regional Medical Center
Cheyenne, Wyoming, United States
JSC Saint Nikolozi Surgery and Oncological Centre
Kutaisi, , Georgia
LTD Institute of Clinical Oncology
Tbilisi, , Georgia
LTD Tbilisi Oncology Dispensary
Tbilisi, , Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, , Georgia
Countries
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References
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Navari R, Binder G, Molasiotis A, Herrstedt J, Roeland EJ, Ruddy KJ, LeBlanc TW, Kloth DD, Klute KA, Papademetriou E, Schmerold L, Schwartzberg L. Duration of Chemotherapy-Induced Nausea and Vomiting (CINV) as a Predictor of Recurrent CINV in Later Cycles. Oncologist. 2023 Mar 17;28(3):208-213. doi: 10.1093/oncolo/oyac240.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NEPA-17-05
Identifier Type: -
Identifier Source: org_study_id
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