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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
441
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy
Lesnoy, Belarus
Minsk City Clinical Oncology Center
Minsk, Belarus
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology
Dobrich, Bulgaria
Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology
Haskovo, Bulgaria
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, 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 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 Acute Phase
Time frame: 0-24 hours
Percentage of Patients With no Emetic Episodes 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 Acute Phase
Time frame: 0-24 hours
Percentage of Patients With no Rescue Medication in the Delayed Phase
Time frame: >24-120 hours
Percentage of Patients With no Rescue Medication in the Overall Phase
Time frame: 0-120 hours
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Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology
Plovdiv, Bulgaria
Complex Oncology Center, Ruse, Department of Medical Oncology
Rousse, Bulgaria
Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"
Sofia, Bulgaria
...and 66 more locations