CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 710 enrolled
Drug / intervention
Casopitant +3 moredrug
Likely dose
Casopitant single intravenous dose (specific dose not stated in record)AI-extracted
Key inclusion· 7
  • ✓Scheduled to receive oxaliplatin 85–130 mg/m² as first-cycle therapy for colorectal cancer, as single IV dose over 2–6 hours on Day 1 only, in combination with 5FU/LV or capecitabine
  • ✓Age ≥18 years
  • ✓ECOG performance status 0, 1, or 2
  • ✓Adequate hematologic and metabolic function including ANC ≥1500/mm³, platelets ≥100,000/mm³, bilirubin ≤1.5 × ULN, and creatinine clearance ≥60 mL/min or serum creatinine ≤1.5 mg/dL
Key exclusion· 14
  • ✕Prior cytotoxic chemotherapy, except adjuvant 5FU/LV or capecitabine if completed ≥6 months before study entry
  • ✕Scheduled to receive chemotherapy with cytotoxic agents (e.g., irinotecan, gemcitabine) or biological agents (e.g., cetuximab, panitumumab) other than protocol-allowed chemotherapy
  • ✕Pregnant or lactating females
  • ✕Radiation therapy within 10 days prior to first study dose or scheduled within 6 days after first study dose in Cycle 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00601172
NCT00601172Phase 3Completed
CompareCT.gov

A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Oxaliplatin Induced Nausea and Vomiting.

GlaxoSmithKline·interventional·Posted Jan 25, 2008·Updated Jan 17, 2018

In Brief

A Phase 3 clinical trial evaluating Casopitant, Dexamethasone, and 2 other interventions for Nausea and Vomiting, Chemotherapy-Induced. Completed, enrolled 710 participants across 96 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea and Vomiting, Chemotherapy-Induced
CountriesBelgium, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Russia, Slovakia, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2008
Enrollment StartMar 10, 2008
Primary CompletionApr 13, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.4 years ago

Interventions

Casopitantdrug

Experimental NK-1 receptor antagonist

Dexamethasonedrug

Standard antiemetics

Placebodrug

Placebo to match IV casopitant

Ondansetrondrug

Standard antiemetics