Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

Summary

This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.

Timeline

Start

2004-12

Primary completion

2006-01

Completion

2006-01

Outcome

Mixed primary results

paper All casopitant doses that were tested significantly increased the proportion of patients with CR: PMID 19834961 ↗

paper casopitant 150 mg compared with 69.4% in the control group (P=.0127); PMID 19834961 ↗

paper Rates of SN did not differ among treatment arms (range, 28%-29%). PMID 19834961 ↗

Publications

• Results Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Casopitant	Small molecule	50 mg	Oral
Subject	Casopitant	Small molecule	100 mg	Oral
Subject	Casopitant	Small molecule	150 mg	Oral
Background	Dexamethasone	Small molecule	—	—
Background	Ondansetron	Other / unclassified	—	—

Indications