An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) 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.
Chemotherapy-Induced Nausea and Vomiting
Drug: Oral palonosetron
Drug: I.V. palonosetron
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy|
- Proportion of patients with complete response (CR) defined as no emesis, no rescue medication [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
- Proportion of patients with no emesis [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
- Proportion of patients with no rescue medication [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Oral palonosteron plus dexamethasone
Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
|Drug: Oral palonosetron Drug: Dexamethasone|
Active Comparator: I.V. palonosetron plus dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
|Drug: I.V. palonosetron Drug: Dexamethasone|
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