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

Completed · Phase 3

Conditions studied: Chemotherapy-induced Nausea and Vomiting

In brief

Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[control\]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.

Key facts

Study ID

NCT03403712

Run by

Helsinn Healthcare SA

People needed

404

Starts

2018-03-16

Expected to finish

2018-09-19

Last updated by the study team

2020-06-01

Who can join

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

You may qualify if…

• Cycle 1:
• The following inclusion criteria must be checked prior to inclusion at Cycle 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.
• Female patient of at least 8 years of age.
• Histologically or cytologically confirmed breast cancer, including recurrent or metastatic.
• Naïve to moderately or highly emetogenic antineoplastic agents.
• Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.
• Notes:
• additional not emetogenic, minimally or low emetogenic antineoplastic agents are permitted at any time after start of AC combination on Day 1.
• 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.
• ECOG Performance Status of 0 or 1.
• 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:
• 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.
• Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence;
• Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy based on investigator's assessment.
• If the patient has a known hepatic or renal impairment, she may be enrolled in the study at the discretion of the Investigator.
• Able to read, understand, follow the study procedure and complete the patient diary.
• All inclusion criteria will be checked at screening visit (Visit 1 of Cycle 1); inclusion criteria 7 will be re-checked at Day 1 (Visit 2).
• 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 an AC chemotherapy regimen or AC chemotherapy together with other chemotherapies as defined in Inclusion criterion #5 for Cycle 1.
• 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.
• Adequate hematologic and metabolic status for receiving a cycle of AC chemotherapy according to the Investigator's opinion.

You may not qualify if…

• Cycle 1:
• The following exclusion criteria must be checked prior to inclusion at Cycle 1:
• Lactating patient.
• Current use of illicit drugs or current evidence of alcohol abuse.
• 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.
• 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.
• 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.
• Symptomatic primary or metastatic central nervous system (CNS) malignancy.
• 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.
• 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).
• Known contraindication to the IV administration of 50 mL 5% glucose solution.
• Participation in a previous clinical trial involving IV fosnetupitant or oral netupitant administered alone or in combination with palonosetron.
• 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.
• 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.
• Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy during the study participation.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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