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NCT01500213 · ClinicalTrials.gov registry record · Phase 3
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
A Phase 3 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
NCT01500213 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 555 participants.
The verdict
NCT01500213, a Phase 3 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Granisetron
- DRUG Rolapitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500213
The ClinicalTrials.gov registry entry for NCT01500213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 555 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01500213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01500213 about?
NCT01500213 is a clinical study titled "Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy". 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 ev...
What is the current status of trial NCT01500213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2012-02. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01500213?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Granisetron (DRUG), Rolapitant (DRUG).
Who is sponsoring clinical trial NCT01500213?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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