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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: Completed Phase 3 study, sponsored by Tesaro.
NCT01500213 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 555 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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 HEC. 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 | 555 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01500213 record still lists
NCT01500213 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01500213 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01500213's enrollment target sits among peer trials
555 676th of 2000 higher than 1,323 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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