NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

NCT03862144 | Completed Phase 2

• 1 other identifier: GIM15-NEPA
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

nausea; vomiting; breast cancer; AC-based chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete response

  The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles

  During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)

Secondary Outcomes (6)

• Acute and Delayed Phase Complete Response

  During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase

• Complete Control

  During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles (each cycle is 21 days), up to 4 cycles

• Emesis-Free

  During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles

• Nausea

  During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles

• Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)

  During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles

Study Arms (1)

Netupitant/Palonosetron & Dexamethasone

EXPERIMENTAL

* Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle. * Dexamethasone 12 mg will be added on day 1 only of each cycle.

Drug: Netupitant/Palonosetron

Interventions

Netupitant/Palonosetron DRUG

Also known as: Netupitant/Palonosetron 300 MG-0.5 MG Oral Capsule [AKYNZEO]

Netupitant/Palonosetron & Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years old
• Histologically or cytologically confirmed diagnosis of breast cancer
• Naïve patients
• Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• Body Mass index (BMI) ≥ 18.5
• Written informed consent
• If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration
• Acceptable hepatic function (\<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine \< 1.5 times the upper limit of normal);
• Ability and willingness of the patient to complete the diary.

You may not qualify if:

• Advanced/metastatic breast cancer
• Patients already submitted to non-AC-based chemotherapy
• Treatment with investigational medications in 30 days before NEPA
• Myocardial infarction within the last 6 months
• Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients
• Uncontrolled diabetes mellitus
• Nausea and vomiting at baseline
• Chronic use of other antiemetic agent(s)
• Patient's inability to take oral medication
• Gastrointestinal obstruction or active peptic ulcer
• Pregnancy or breastfeeding
• Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years
• Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol

Sponsors & Collaborators

• Consorzio Oncotech: lead

Related Publications (1)

• Caputo R, Cazzaniga ME, Sbrana A, Torrisi R, Paris I, Giordano M, Montesarchio V, Guarneri V, Amaducci L, Bilancia D, Cilenti G, Fabi A, Collova E, Schirone A, Bonizzoni E, Celio L, De Placido S, De Laurentiis M. Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study. BMC Cancer. 2020 Mar 19;20(1):232. doi: 10.1186/s12885-020-6707-9.

  PMID: 32188417 DERIVED

MeSH Terms

Conditions

Vomiting; Nausea; Breast Neoplasms

Interventions

netupitant, palosentron drug combination; netupitant; Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michelino De Laurentiis, MD, PhD

  National Cancer Institute "Fondazione Pascale", Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II study, one stage Fleming design, open-label, multicenter, not comparative

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 5, 2019
• Study Start: May 12, 2016
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: March 5, 2019

Record last verified: 2019-03