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Chemotherapy Induced Nausea and VomitingPhase 2NCT02205164

Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

A Phase 2 study testing Palonosetron + Aprepitant and Palonosetron in people with Chemotherapy Induced Nausea and Vomiting, run by Associazione Salentina Angela Serra at 11 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy Induced Nausea and Vomiting
What is being tested?
Palonosetron + Aprepitant and Palonosetron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
11 sitesItaly
Study dates
Oct 2011to Oct 2014
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS
  • Patient eligible for AML-like induction therapy
  • Candidate for multiple-days chemotherapy (minimum 3 days)
  • Age more, equal18 years
  • ECOG 0-2
  • Not pregnant or nursing
  • Must be able to complete the patient's diary
  • Provide written informed consent

Who cannot join

  • AML or HR-MDS therapy-related
  • Active infection requiring intravenous antibiotics
  • Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years
  • Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related
  • Myocardial infarction within the past 6 months
  • Psychiatric or CNS disorders interfering with ability to comply with study protocol
  • Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement
  • Pre-existing nausea or vomiting

Trial locations and contacts

11 sites in 1 country.

Nicola Di Renzo, MD contact

direnzo.ematolecce@libero.it

Claudia Quintavalle, BsC contact

quinta.ematolecce@libero.it

11 sites in 1 country

Italy11 sites, 9 recruiting

  • Università-Azienda Policlinico di Bari

    Bari, BA, 70124

    Active, not recruiting

  • Ospedale Perrino

    Brindisi, BR, 72010

    Angela Melpignano, MD, brinemat@tin.it

    Angela Melpignano, MD

    Recruiting

  • Ospedale Pugliese-Ciacco

    Catanzaro, CZ, 88100

    Active, not recruiting

  • Ospedale Vito Fazzi

    Lecce, LE, 73100

    Nicola Di Renzo, MD, direnzo.ematolecce@libero.it

    Nicola Di Renzo, MD

    Recruiting

  • A.O. Riuniti Papardo - Piemonte

    Messina, ME, 98121

    Donato Mannina, MD, donadani@tiscali.it

    Donato Mannina, MD

    Recruiting

  • ARON " Cardarelli"

    Naples, 80121

    Felicetto Ferrara, MD, felicettoferrara@katamail.com

    Felicetto Ferrara, MD

    Recruiting

  • Casa di Cura "La Maddalena"

    Palermo, PA, 90127

    Maurizio Musso, MD, mamusso@libero.it

    Maurizio Musso, MD

    Recruiting

  • Ospedale Ascoli Civico Palermo

    Palermo, PA, 90127

    Anxur Merenda, MD, anxurmerenda@libero.it

    Anxur Merenda, MD

    Recruiting

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

    Nicola Cascavilla, MD, nicola.cascavilla@tin.it

    Nicola Cascavilla, MD

    Recruiting

  • Ospedale Moscati

    Taranto, TA, 74100

    Patrizio Mazza, MD, ematologia.taranto@libero.it

    Patrizio Mazza, MD

    Recruiting

  • Ospedale "Cardinale Panico"

    Tricase, LE, 73100

    Vincenzo Pavore, MD, salentoematologia@piafondazionepanico.it

    Vincenzo Pavone, MD

    Recruiting

Other trials in Italy

About this study

Official title: Phase II Randomized Study of Multiple Doses of Palonosetron Plus Aprepitant Versus Multiple Doses of Palonosetron Alone in Preventing CINV in Patients With Newly Diagnosed AML or High-risk MDS Receiving Multiple Days Chemotherapy

The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.

Read the detailed description

This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy.

Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens:

PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

Being tested
Palonosetron + Aprepitant, Palonosetron
Keywords
palonosetron, aprepitant, CINV, AML, multiple-days
Medical subject headings
Vomiting

What participants receive

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

  • Palonosetron + AprepitantDrug

    Also called Aloxi + Emend

    Aloxi 0.25mg Emend 125/80/80 mg

  • PalonosetronDrug

    Also called Aloxi

    Aloxi 0.25mg

Study groups in NCT02205164
Study groupRoleWhat they receive
Palonosetron + AprepitantExperimentalOral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
Receives: Drug: Palonosetron + Aprepitant
PalonosetronActive comparatormultiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
Receives: Drug: Palonosetron

What is being measured

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

  1. Complete Response

    The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.

    Measured: 5 days after chemotherapy

Secondary outcomes (6)

  1. Complete Control

    No emetic episode, no need for rescue medication, with a maximum grade of mild nausea

    Measured: 5 days after chemotherapy

  2. Emesis-free

    Percentage of patients without emetic episodes

    Measured: 5 days after chemotherapy

  3. Presence of nausea

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

    Measured: 5 days after chemotherapy

  4. Treatment failure

    Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)

    Measured: 5 days after chemotherapy

  5. Patient global satisfaction

    Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)

    Measured: 5 days after chemotherapy

  6. Safety and tolerability

    Number of patients experienced at least one adverse events related to study drug administration.

    Measured: 5 days after chemotherapy

Timeline

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

  1. First posted31 Jul 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionAug 2014 (estimated)
  4. Study completionOct 2014 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205164
Sponsor's protocol ID
AS/PALO/002
Other IDs
2011-003823-36
Status last verified
Jul 2014
First submitted
17 Jul 2014
Last updated
31 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Di Renzo N, Melillo L, Porretto F, Dargenio M, Pavone V, Pastore D, Mazza P, Mannina D, Merenda A, Cascavilla N, Greco G, Matera R, Bonizzoni E, Celio L, Musso M. Every-other-day palonosetron plus aprepitant for prevention of emesis following induction chemotherapy for acute myeloid leukemia: A randomized, controlled study from the "Rete Ematologica Pugliese". Cancer Med. 2020 Jan;9(1):170-178. doi: 10.1002/cam4.2628. Epub 2019 Nov 14.

    PubMed 31725196

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palonosetron + Aprepitant and Palonosetron in people with Chemotherapy Induced Nausea and Vomiting, run by Associazione Salentina Angela Serra at 11 sites in Italy.

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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Nicola Di Renzo, MD (direnzo.ematolecce@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (time frame: 5 days after chemotherapy). 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 NCT02205164, 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 31 Jul 2014.

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