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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: Completed Phase 3 study, sponsored by Tesaro.
NCT01500226 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 1,369 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (\>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (\>24 to 120 hours).
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 |
What the finished NCT01500226 record still lists
NCT01500226 is an interventional study that assigns participants to a tested intervention. Its 1,369 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01500226 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01500226's enrollment target sits among peer trials
1,369 179th of 2000 higher than 1,822 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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