18 and older, any sex, with Nausea and Vomiting, Chemotherapy-Induced. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) RegimenPrimary· 0 to 120 hours in the first cycle of chemotherapy
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began
Group
Value
95% CI
Placebo
85
Casopitant 90 mg
86
Percentage of Participants Who Achieved a Complete Response in the Acute Phase of Cycle 1Secondary· 0 to 24 hours in the first cycle of chemotherapy
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participan
Group
Value
95% CI
Placebo
96
Casopitant 90 mg
97
Percentage of Participants Who Achieved a Complete Response in the Delayed Phase of Cycle 1Secondary· 24 to 120 hours (delayed phase) in the first cycle of chemotherapy
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. Percentage of participan
Group
Value
95% CI
Placebo
85
Casopitant 90 mg
86
Percentage of Participants Who Achieved a Complete Response in the Overall Phase of Cycle 2Secondary· 0 to 120 hours in the second cycle of chemotherapy
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 hours) phase were not considered as failures in the acute (0-24 hours) phase. The overall phase began
Group
Value
95% CI
Placebo
84
Casopitant 90 mg
90
Maximum Nausea Score, Assessed by a Visual Analogue Scale (VAS)Secondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS.
0-120 hours
Group
Value
95% CI
Placebo
13.5
± 23.3
Casopitant 90 mg
16.0
± 24.5
0-24 hours
Group
Value
95% CI
Placebo
4.3
± 12.9
Casopitant 90 mg
5.3
± 13.3
24-120 hours
Group
Value
95% CI
Placebo
13.0
± 22.6
Casopitant 90 mg
15.3
± 24.2
Percentage of Participants Who Received Rescue MedicationSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
Anti-emetic rescue medication was defined as medication that was administered specifically for the treatment of nausea and/or emesis during Days 1-6 of each cycle. The choice of rescue anti-emetic medication was left to the discretion of the investigator. Participants who required antiemetic rescue medication(s) during the 120-hour assessment period were considered treatment failures for that cycle. Percentage of participants who received rescue medication are presented.
0-120 hours
Group
Value
95% CI
Placebo
9
Casopitant 90 mg
8
0-24 hours
Group
Value
95% CI
Placebo
2
Casopitant 90 mg
1
24-120 hours
Group
Value
95% CI
Placebo
9
Casopitant 90 mg
8
Percentage of Participants Who Vomited and/or RetchedSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that is not productive of gastrointestinal contents (also known as dry heaves). If a participant took rescue medication but there was no evidence of vomiting or retching, then the participant was considered as not having vomited. Percentage of participants who vomited and/or retched during the first 120 hours of the first cycle of chemotherapy are presented.
0-120 hours
Group
Value
95% CI
Placebo
11
Casopitant 90 mg
10
0-24 hours
Group
Value
95% CI
Placebo
3
Casopitant 90 mg
2
24-120 hours
Group
Value
95% CI
Placebo
11
Casopitant 90 mg
10
Percentage of Participants Who Reported Significant Nausea, Defined as a Maximum Score >= 25 mm on the VASSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported significant nausea, defined as a maximum score \>= 25 mm on the VAS are presented.
0-120 hours
Group
Value
95% CI
Placebo
19
Casopitant 90 mg
21
0-24 hours
Group
Value
95% CI
Placebo
4
Casopitant 90 mg
5
24-120 hours
Group
Value
95% CI
Placebo
19
Casopitant 90 mg
21
Percentage of Participants Who Reported Nausea, Defined as a Maximum Score of >= 5 mm on the VASSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
VAS was used to assess severity of nausea. The participants rated the severity of nausea by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no nausea and extreme right that is 100 mm indicated nausea as bad as it can be. This scale has no subscales. The participant perception of their symptoms was measured using the VAS. Percentage of participants who reported nausea, defined as a maximum score of \>= 5 mm on the VAS are presented.
0-120 hours
Group
Value
95% CI
Placebo
37
Casopitant 90 mg
45
0-24 hours
Group
Value
95% CI
Placebo
12
Casopitant 90 mg
15
24-120 hours
Group
Value
95% CI
Placebo
37
Casopitant 90 mg
45
Percentage of Participants Who Achieved Complete Protection Defined as Complete Responders With no Significant NauseaSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
Complete protection was defined as no vomiting/retching, no use of rescue medication and no significant nausea. Percentage of participants who achieved complete protection or complete responders with no significant nausea are presented.
0-120 hours
Group
Value
95% CI
Placebo
75
Casopitant 90 mg
74
0-24 hours
Group
Value
95% CI
Placebo
93
Casopitant 90 mg
93
24-120 hours
Group
Value
95% CI
Placebo
75
Casopitant 90 mg
74
Percentage of Participants Who Achieved Total Control, Defined as Complete Responders Who Had no NauseaSecondary· 0 to 24 hours, 24 to 120 hours and 0 to 120 hours in the first cycle of chemotherapy
Total control was defined as no vomiting/retching, no use of rescue medication and no nausea. Percentage of participants who achieved total control or complete responders with no nausea are presented.
0-120 hours
Group
Value
95% CI
Placebo
61
Casopitant 90 mg
54
0-24 hours
Group
Value
95% CI
Placebo
88
Casopitant 90 mg
83
24-120 hours
Group
Value
95% CI
Placebo
61
Casopitant 90 mg
54
Percentage of Participants Whose Daily Life Activities Were Impacted in the Overall Phase of Cycle 1, Assessed by Functional Living Index-Emesis (FLIE) QuestionnaireSecondary· 0 to 120 hours in the first cycle of chemotherapy
FLIE questionnaire specifically addresses the impact of nausea and vomiting on daily activities (physical, social and emotional function, ability to enjoy meals). It consists of 18 items with questions divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). Each item is scored on a VAS with 7 hatch marks. The scale is anchored at 1 (Not at all) and 7 (A great deal). For questions 1,2,4,5,7,8-10,12-14,16 and 17 the final score was calculated by subtracting the initial score from 100 for questions 3,6,11,15 and 18 the final score was the one provided in the dataset. The
Nausea impact
Group
Value
95% CI
Placebo
21.3
Casopitant 90 mg
23.7
Vomiting impact
Group
Value
95% CI
Placebo
12.5
Casopitant 90 mg
11.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 35 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 17 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00601172.