Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Phase 3

Completed

• Conditions: Vomiting; Nausea; Nausea and Vomiting, Chemotherapy-Induced
• Interventions: Drug: Casopitant (GW679769) oral tablets; Drug: Casopitant (GW679769) intravenous; Drug: Ondansetron oral tablets; Drug: Dexamethasone intravenous; Drug: placebo

• Registration Number: NCT00366834
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Detailed Description

A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-21
• Primary Completion: 2007-10
• Study Completion: 2009-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1840

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-day oral	Ondansetron oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3
3-day IV/oral	Dexamethasone intravenous	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3
3-day IV/oral	Ondansetron oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3
Single dose oral	Ondansetron oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
Control	Dexamethasone intravenous	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Control	Ondansetron oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Control	placebo	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Single dose oral	Casopitant (GW679769) oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
Single dose oral	Dexamethasone intravenous	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
3-day oral	Casopitant (GW679769) oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3
3-day oral	Dexamethasone intravenous	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3
3-day IV/oral	Casopitant (GW679769) oral tablets	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3
3-day IV/oral	Casopitant (GW679769) intravenous	ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3

Primary Outcome Measures

Name	Time	Method
Complete response as assessed by a visual analogue scale and a subject diary over the 120 hours following the first cycle of chemotherapy.	120 Hours

Secondary Outcome Measures

Name	Time	Method
Complete response over 120 hours following subsequent chemotherapy cycles Use of rescue medication over 120 hours following all chemotherapy cycles Impact on daily life activities over 120 hours, assessed using a subject diary questionnaire	120 Hours
The proportion of subjects who achieve a complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of MEC.	approx. 18 mos
The proportion of subjects who achieve a complete response over the first 120 hours, during the acute (0-24 hours), the delayed (24-120 hours), and the overall (0-120 hours) phase following subsequent cycles of MEC.	approx. 18 mos
Maximum nausea score (to assess the severity of nausea), as assessed by a Visual Analogue Scale (VAS) over the first 120 hours and in the acute and delayed phases following each cycle of MEC.	approx. 18 mos
Time to first antiemetic rescue medication, defined as the time elapsed from the start of administration of the MEC regimen to the first use of antiemetic rescue medication.	approx. 18 mos
If a subject withdraws prematurely during the first 120 hours, then the time of withdrawal will be considered to be their time to first use of antiemetic rescue medication, and will be censored.	approx. 18 mos
Time to first emetic event, defined as the time elapsed from the start of administration of the MEC regimen to the first emetic episode. If a subject withdraws prematurely during the first 120 hours,	approx. 18 mos
then the time of withdrawal will be considered to be their time to first emetic episode, and will be censored.	approx. 18 mos
The proportion of subjects who receive rescue medication.	approx. 18 mos
The proportion of subjects reporting significant nausea defined as a maximum nausea score greater than or equal to 25 mm on the VAS.	approx. 18 mos
The proportion of subjects reporting nausea defined as a maximum nausea score greater than or equal to 5 mm on the VAS.	approx. 18 mos
The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.	approx. 18 mos
The impact on subjects' daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the FLIE questionnaire.	approx. 18 mos
Subject satisfaction with the prophylactic antiemetic regimens, and the willingness of subjects to use the same treatment during future chemotherapy, as assessed by the Subject Satisfaction\Willingness Assessment in the Subject Diary.	approx. 18 mos
Nausea as assessed by a categorical scale, over the first 120 hours following MEC administration.	approx. 18 mos
Assessment of the safety and tolerability of casopitant through: routine physical exam, routine clinical laboratory tests, clinical monitoring and adverse events reporting.	approx. 18 mos
The proportion of subjects who vomit/retch.	approx. 18 mos
The proportion of subjects achieving total control, defined as complete responders who had no nausea.	approx. 18 mos

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Shrewsbury, United Kingdom