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

NCT01500213 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2016-03-02

Study results available
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Summary

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

Rolapitant

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) o mg PO

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Vargo, MD · Tesaro, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500213 on ClinicalTrials.gov