Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

532

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
DRUG

Rolapitant

(4 X 50 mg capsules) 200 mg PO

DRUG

Granisetron

10 mcg/kg IV

DRUG

dexamethasone

20 mg PO and 8 mg PO

DRUG

Placebo

(4 X 0 mg capsules) 0 mg PO

Trial Locations (1)

02451

TESARO Inc, Waltham

All Listed Sponsors
lead

Tesaro, Inc.

INDUSTRY

NCT01499849 - Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy | Biotech Hunter | Biotech Hunter