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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557035
Recruitment Status : Completed
First Posted : September 22, 2015
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
PSI CRO AG
Information provided by (Responsible Party):
Helsinn Healthcare SA

Brief Summary:
PALO-15-17 is a clinical study assessing efficacy and safety of a single dose 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 (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Nausea and Vomiting Drug: Palonosetron Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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.
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: I.V. palonosetron infusion plus dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Drug: Palonosetron
Drug: Dexamethasone
Active Comparator: I.V. palonosetron bolus plus dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Drug: Palonosetron
Drug: Dexamethasone



Primary Outcome Measures :
  1. 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 Measures :
  1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase [ Time Frame: >24-120 hours ]
  2. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase [ Time Frame: 0-120 hours ]
  3. Percentage of Patients With no Emetic Episodes in the Acute Phase [ Time Frame: 0-24 hours ]
  4. Percentage of Patients With no Emetic Episodes in the Delayed Phase [ Time Frame: >24-120 hours ]
  5. Percentage of Patients With no Emetic Episodes in the Overall Phase [ Time Frame: 0-120 hours ]
  6. Percentage of Patients With no Rescue Medication in the Acute Phase [ Time Frame: 0-24 hours ]
  7. Percentage of Patients With no Rescue Medication in the Delayed Phase [ Time Frame: >24-120 hours ]
  8. Percentage of Patients With no Rescue Medication in the Overall Phase [ Time Frame: 0-120 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557035


Locations
Show Show 76 study locations
Sponsors and Collaborators
Helsinn Healthcare SA
PSI CRO AG
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Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT02557035    
Other Study ID Numbers: PALO-15-17
First Posted: September 22, 2015    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action