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Casopitant

Phase 3

Vomiting | Small molecule | Other |GSK plc|Last Updated: Aug 4, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment1,858
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00366834Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And VomitingPHASE3 COMPLETED 1,840 — — Jul 1, 2006Oct 1, 2009Sep 10, 2012223 United States, Argentina +30
NCT00358813Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal ImpairmentPHASE1 COMPLETED 18 — — Sep 8, 2006Aug 22, 2008Aug 4, 20173 United States
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Study Endpoints
Primary Endpoints
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
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

Blood samples will be collected at the indicated time points for pharmacokinetic analysis.

Maximum observed concentration (Cmax) of casopitant and GSK525060
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

Blood samples will be collected at the indicated time points for pharmacokinetic analysis.

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ControlPLACEBO_COMPARATORondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Single dose oralEXPERIMENTALondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
3-day oralEXPERIMENTALondansetron 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/oralEXPERIMENTALondansetron 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
Subjects receiving casopitantEXPERIMENTALEligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
Interventions
NameTypeDescription
Casopitant (GW679769) oral tabletsDRUG -
Casopitant (GW679769) intravenousDRUG -
Dexamethasone intravenousDRUG -
Ondansetron oral tabletsDRUG -
placeboDRUGcasopitant placebo
CasopitantDRUGCasopitant oral tablets will be available with a dose of 50 milligrams.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites223

Inclusion criteria: * A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: * Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understand...

Countries:United StatesArgentinaAustriaBelgiumBulgariaCanadaCroatiaCzechiaDenmarkEstoniaGermanyGreeceHong KongHungaryIndiaIrelandItalyLatviaLithuaniaMexicoPakistanPeruPhilippinesPolandRussiaSlovakiaSouth AfricaSouth KoreaSpainTaiwanThailandUnited Kingdom
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