Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Chemotherapy-induced Nausea and Vomiting, sponsored by Tesaro.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 emetic episodes and no rescue medication) in the delayed phase (\>24 to 120 hours).
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 |
What the finished NCT01499849 record still lists
NCT01499849 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 3 other Chemotherapy-induced Nausea and Vomiting trials with a reported enrollment target (96% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chemotherapy-induced Nausea and Vomiting
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05793151 · 532 participants · NA
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
- NCT06378866 · 532 participants · Phase 2
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
- NCT07219173 · 531 participants · Phase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
- NCT04910685 · 534 participants · Phase 2
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia