Trial · NCT01500226
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
NCT01500226, Phase 3, Completed, Tesaro, Inc.; results first posted 2015-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy. Trials, record NCT01500226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01500226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
- NCT number
- NCT01500226
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,369 participants, actual
- Lead sponsor
- Tesaro, Inc.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- Rolapitant, Granisetron, Dexamethasone, Placebo
- First posted
- 2011-12-28
- Last updated
- 2016-03-02
- Results first posted
- 2015-11-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | No Emetic Episodes and No Rescue Medication | >24 to 120 hours post chemotherapy | 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). |
| Secondary | Acute Phase Response | 0 to 24 hours | To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV. |
| Secondary | Overall Response Rate | 0 to 120 hours | To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | No Emetic Episodes and No Rescue Medication | >24 to 120 hours post chemotherapy | MITT | percentage of particpants | NUMBER |
| SECONDARY | Acute Phase Response | 0 to 24 hours | MITT | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate | 0 to 120 hours | MITT | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| No Emetic Episodes and No Rescue Medication | Rolapitant + Granisetron + Dexamethasone | 71.3 | 95% Confidence Interval 67.7 to 74.7 | percentage of particpants | |
| No Emetic Episodes and No Rescue Medication | Placebo + Granisetron + Dexamethasone | 61.6 | 95% Confidence Interval 57.7 to 65.3 | percentage of particpants | |
| Acute Phase Response | Rolapitant + Granisetron + Dexamethasone | 83.5 | 95% Confidence Interval 80.4 to 86.2 | percentage of participants | |
| Acute Phase Response | Placebo + Granisetron + Dexamethasone | 80.3 | 95% Confidence Interval 77.1 to 83.3 | percentage of participants | |
| Overall Response Rate | Rolapitant + Granisetron + Dexamethasone | 68.6 | 95% Confidence Interval 64.9 to 72.1 | percentage of participants | |
| Overall Response Rate | Placebo + Granisetron + Dexamethasone | 57.8 | 95% Confidence Interval 54.0 to 61.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rolapitant + Granisetron + Dexamethasone | 684 | |
| Overall Study | STARTED | Placebo + Granisetron + Dexamethasone | 685 | |
| Overall Study | COMPLETED | Rolapitant + Granisetron + Dexamethasone | 185 | |
| Overall Study | COMPLETED | Placebo + Granisetron + Dexamethasone | 191 | |
| Overall Study | NOT COMPLETED | Rolapitant + Granisetron + Dexamethasone | 499 | |
| Overall Study | NOT COMPLETED | Placebo + Granisetron + Dexamethasone | 494 |
Source ClinicalTrials.gov
Adverse events250
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Rolapitant + Granisetron + Dexamethasone | 67 | 670 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Granisetron + Dexamethasone | 50 | 674 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rolapitant + Granisetron + Dexamethasone | 37 | 670 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Granisetron + Dexamethasone | 31 | 674 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rolapitant + Granisetron + Dexamethasone | 96 | 670 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Granisetron + Dexamethasone | 84 | 674 | |
| other | Abdominal Pain | Gastrointestinal disorders | Rolapitant + Granisetron + Dexamethasone | 34 | 670 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo + Granisetron + Dexamethasone | 31 | 674 | |
| other | Constipation | Gastrointestinal disorders | Rolapitant + Granisetron + Dexamethasone | 114 | 670 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Granisetron + Dexamethasone | 138 | 674 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rolapitant + Granisetron + Dexamethasone | ||
| Total, all-cause mortality | Placebo + Granisetron + Dexamethasone | ||
| Total, other adverse events | Rolapitant + Granisetron + Dexamethasone | 540 | 670 |
| Total, other adverse events | Placebo + Granisetron + Dexamethasone | 542 | 674 |
| Total, serious adverse events | Rolapitant + Granisetron + Dexamethasone | 89 | 670 |
| Total, serious adverse events | Placebo + Granisetron + Dexamethasone | 103 | 674 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26272768 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rolapitant + Granisetron + Dexamethasone vs Placebo + Granisetron + Dexamethasone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01500226
GET https://conductscience.org/api/trials/v1/NCT01500226/events?page=2