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Chemotherapy-induced Nausea and VomitingPhase 2GIM15-NEPANCT03862144

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

A Phase 2 study testing Netupitant/Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by Consorzio Oncotech.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Chemotherapy-induced Nausea and Vomiting
What is being tested?
Netupitant/Palonosetron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
12 May 2016to 3 Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

About this study

Official title: One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen

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).

Read the detailed description

Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:

  • NEPA will be administered orally at the dose of 300 mg 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.
Being tested
Netupitant/Palonosetron
Keywords
nausea, vomiting, breast cancer, AC-based chemotherapy
Medical subject headings
Vomiting, Nausea, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netupitant/PalonosetronDrug

    Also called Netupitant/Palonosetron 300 MG-0.5 MG Oral Capsule [AKYNZEO]

Study groups in NCT03862144
Study groupRoleWhat they receive
Netupitant/Palonosetron & DexamethasoneExperimental* 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.
Receives: Drug: Netupitant/Palonosetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Acute and Delayed Phase Complete Response

    Rate of complete control (defined as no emetic episode and no need for rescue medication)

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

  2. Complete Control

    Rate of complete control (defined as complete response with a maximum grade of mild nausea)

    Measured: 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

  3. Emesis-Free

    Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration.

    Measured: 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

  4. Nausea

    Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

    Measured: 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

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

    Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)

    Measured: 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

  6. Safety profile (according to CTCAE)

    Safety profile according to CTCAE

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start12 May 2016
  3. Primary completion3 Apr 2017
  4. Study completion3 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Phase II study, one stage Fleming design, open-label, multicenter, not comparative
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03862144
Sponsor's protocol ID
GIM15-NEPA
Acronym
GIM15-NEPA
Status last verified
Mar 2019
First submitted
14 Jan 2019
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32188417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Netupitant/Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, run by Consorzio Oncotech.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03862144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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