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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02205164
Other study ID # AS/PALO/002
Secondary ID 2011-003823-36
Status Recruiting
Phase Phase 2
First received July 17, 2014
Last updated July 30, 2014
Start date October 2011
Est. completion date October 2014

Study information

Verified date July 2014
Source Associazione Salentina Angela Serra
Contact Nicola Di Renzo, MD
Email direnzo.ematolecce@libero.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 134
Est. completion date October 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Palonosetron + Aprepitant
Aloxi 0.25mg Emend 125/80/80 mg
Palonosetron
Aloxi 0.25mg

Locations

Country Name City State
Italy Università-Azienda Policlinico di Bari Bari BA
Italy Ospedale Perrino Brindisi BR
Italy Ospedale Pugliese-Ciacco Catanzaro CZ
Italy Ospedale Vito Fazzi Lecce LE
Italy A.O. Riuniti Papardo - Piemonte Messina ME
Italy ARON " Cardarelli" Napoli
Italy Casa di Cura "La Maddalena" Palermo PA
Italy Ospedale Ascoli Civico Palermo Palermo PA
Italy IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo FG
Italy Ospedale Moscati Taranto TA
Italy Ospedale "Cardinale Panico" Tricase LE

Sponsors (1)

Lead Sponsor Collaborator
Associazione Salentina Angela Serra

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 days after chemotherapy No
Secondary Complete Control No emetic episode, no need for rescue medication, with a maximum grade of mild nausea 5 days after chemotherapy No
Secondary Emesis-free Percentage of patients without emetic episodes 5 days after chemotherapy No
Secondary Presence of nausea Presence of nausea graded according to Likert scale (none, mild, moderate and severe) 5 days after chemotherapy No
Secondary Treatment failure Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) 5 days after chemotherapy No
Secondary Patient global satisfaction Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS) 5 days after chemotherapy No
Secondary Safety and tolerability Number of patients experienced at least one adverse events related to study drug administration. 5 days after chemotherapy No
See also
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Completed NCT01362530 - A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208) Phase 3
Completed NCT01596400 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years Phase 1
Not yet recruiting NCT04873284 - Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients N/A
Completed NCT00642512 - Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Phase 3
Recruiting NCT02097823 - Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy Phase 2
Completed NCT01402024 - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy Phase 3
Completed NCT00211601 - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041) N/A
Completed NCT05792228 - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting N/A
Withdrawn NCT01596413 - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years Phase 1
Withdrawn NCT01596426 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years Phase 1