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Vomiting

Signs and Symptoms, Digestive

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Dexamethasone

Palonosetron

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0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).

Palonosetron and Dexamethasone

The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.

Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)

Open-label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-induced Nausea and Vomit (CINV).

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme LLC

Anti-Infective Agents

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Thalidomide 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.

Placebo (for Thalidomide) tablet 100 mg by mouth twice a day on days 1-5; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.

100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1

Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1

Placebo for thalidomide

Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.

Yunpeng Liu, MD., PhD

This study was aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients after highly emetogenic chemotherapy.

This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the study. Patients treating with highly emetogenic chemotherapy will be randomized into two groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo + Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate (CRR) for delayed CINV, and the secondary end points include the safety and quality of life (QOL).

Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting

Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting From Highly Emetogenic Chemotherapy: a Randomized, Multicenter, Double-blind, Placebo-controlled Phase III Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)	NCT00687011	Neoplasms Nausea Vomiting	Palonosetron an...	18 Years -	Merck Sharp & Dohme LLC
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting	NCT02203253	Neoplasms	Thalidomide Placebo for tha... Palonosetron an...	18 Years - 70 Years	China Medical University, China
Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)	NCT00687011	Neoplasms Nausea Vomiting	Palonosetron an...	18 Years -	Merck Sharp & Dohme LLC

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