An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02557035
• Date of registration: 21/09/2015
• Prospective Registration: Yes
• Primary sponsor: Helsinn Healthcare SA
• Public title: An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
• Scientific title: A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.
• Date of first enrolment: October 2015
• Target sample size: 441
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02557035
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belarus, Bosnia and Herzegovina, Bulgaria, Georgia, Greece, Hungary, Lithuania, Romania, Russian Federation

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed written informed consent

- Histologically or cytologically confirmed solid tumor malignancy.

- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be
permitted.

- Scheduled to receive first course of one of the following reference HEC, alone or in
combination with other chemotherapeutic agents on Day 1:

- cisplatin administered as a single IV dose of = 70 mg/m2

- cyclophosphamide =1500 mg/m2

- carmustine (BCNU) >250 mg/m2

- dacarbazine (DTIC)

- mechloretamine (nitrogen mustard)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .

- If a patient is female, she shall be of non-childbearing potential or of childbearing
potential using reliable contraceptive measures and having a negative urine pregnancy
test.

- Hematologic and metabolic status adequate for receiving an highly emetogenic regimen
based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes,
Serum Creatinine or Creatinine Clearance)

- Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria:

- Lactating woman.

- Current use of illicit drugs or current evidence of alcohol abuse.

- Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic
chemotherapy from Day 2 to Day 5.

- Received or is scheduled to receive radiation therapy to the abdomen or the pelvis
within 1 week prior to the start of the reference HEC administration on Day 1 or
between Days 1 to 5.

- Any vomiting, retching, or nausea (grade = 1 as defined by National Cancer Institute)
within 24 hours prior to the start of the reference HEC administration on Day 1.

- Symptomatic primary or metastatic 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) or pose unwarranted risks in
administering the study drugs to the patient.

- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists

- Known contraindication to the IV administration of 50 mL 5% glucose solution.

- Participation in a previous clinical trial involving palonosetron.

- Any investigational drugs (other than those given in this study) taken within 4 weeks
prior to Day 1, and/or is scheduled to receive any investigational drug during the
present study.

- Systemic corticosteroid therapy at any dose within 72 hours prior to the start of the
reference HEC administration on Day 1. However, topical and inhaled corticosteroids
are permitted.

- Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.

- Any medication with known or potential antiemetic activity within 24 hours prior to
the start of the reference HEC administration on Day 1, including but not limited to
5-HT3 receptor antagonists and NK-1 receptor antagonists

- Concurrent medical condition that would preclude administration of dexamethasone for 4
days such as systemic fungal infection or uncontrolled diabetes.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chemotherapy-Induced Nausea and Vomiting

Intervention(s)

Drug: Palonosetron

Drug: Dexamethasone

Primary Outcome(s)

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase [Time Frame: 0-24 hours]

Secondary Outcome(s)

Percentage of Patients With no Emetic Episodes in the Acute Phase [Time Frame: 0-24 hours]

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase [Time Frame: >24-120 hours]

Percentage of Patients With no Emetic Episodes in the Overall Phase [Time Frame: 0-120 hours]

Percentage of Patients With no Rescue Medication in the Delayed Phase [Time Frame: >24-120 hours]

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase [Time Frame: 0-120 hours]

Percentage of Patients With no Emetic Episodes in the Delayed Phase [Time Frame: >24-120 hours]

Percentage of Patients With no Rescue Medication in the Acute Phase [Time Frame: 0-24 hours]

Percentage of Patients With no Rescue Medication in the Overall Phase [Time Frame: 0-120 hours]

Secondary ID(s)

PALO-15-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PSI CRO AG

Results

• Results available: Yes
• Date Posted: 20/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02557035