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NCT01499849 · 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 of Chemotherapy-induced Nausea and Vomiting, sponsored by Tesaro.
- Completed
- Registry status
- Phase 3
- Development phase
- 532
- Enrollment target
- 1
- Study location
NCT01499849 is a Phase 3 study of Chemotherapy-induced Nausea and Vomiting that has completed, run by Tesaro. The registered enrollment target is 532 participants, above the 272-participant average among 3 other Chemotherapy-induced Nausea and Vomiting trials with a reported enrollment target (96% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01499849, a Phase 3 study of Chemotherapy-induced Nausea and Vomiting, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 532 participants
- Enrollment target
- 1
- Study location
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 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 Studied
Interventions
- DRUG Placebo
- DRUG dexamethasone
- DRUG Granisetron
- DRUG Rolapitant
Study Locations (1)
Massachusetts
- TESARO Inc - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01499849
The ClinicalTrials.gov registry entry for NCT01499849 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 272-participant average among 3 other Chemotherapy-induced Nausea and Vomiting trials with a reported enrollment target (96% higher). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chemotherapy-induced Nausea and Vomiting appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01499849 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01499849 about?
NCT01499849 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 prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of em...
What is the current status of trial NCT01499849?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 532 participants. The study started on 2012-02. Estimated completion is 2014-05.
What conditions does trial NCT01499849 study?
This clinical trial studies the following conditions: Chemotherapy-induced Nausea and Vomiting.
What interventions are being tested in trial NCT01499849?
The interventions under investigation include: Placebo (DRUG), dexamethasone (DRUG), Granisetron (DRUG), Rolapitant (DRUG).
Who is sponsoring clinical trial NCT01499849?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01499849 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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