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NCT01500226 · ClinicalTrials.gov registry record · Phase 3
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
A Phase 3 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,369
- Enrollment target
NCT01500226 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 1,369 participants.
The verdict
NCT01500226, a Phase 3 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,369 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the 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 the MEC administration through Day 6 in 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 examination, 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 | 1,369 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500226
The ClinicalTrials.gov registry entry for NCT01500226 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,369 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.
NCT01500226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01500226 about?
NCT01500226 is a clinical study titled "Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy". This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events o...
What is the current status of trial NCT01500226?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,369 participants. The study started on 2012-02. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01500226?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Granisetron (DRUG), Rolapitant (DRUG).
Who is sponsoring clinical trial NCT01500226?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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