Trial · NCT02106494
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
NCT02106494, Phase 3, Completed, Heron Therapeutics; results first posted 2016-12-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC. Trials, record NCT02106494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106494
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
- NCT number
- NCT02106494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 942 participants, actual
- Lead sponsor
- Heron Therapeutics
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- APF530, Ondansetron, Ondansetron placebo, APF530 placebo, Fosaprepitant, Dexamethasone
- First posted
- 2014-04-08
- Last updated
- 2026-03-02
- Results first posted
- 2016-12-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delayed Phase Complete Response (CR) Rate | 24 - 120 Hours | Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV. |
| Secondary | Overall Complete Response Rate | 0 - 120 Hours | To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV. |
| Secondary | Delayed Complete Control (CC) Rate | 24 - 120 Hours | To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes \[vomiting or retching\], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV. |
| Secondary | Overall Complete Control Rate | 0 - 120 Hours | To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes \[vomiting or retching\], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV. |
| Secondary | Rate of No Emetic Episodes | 0 - 120 Hours | To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delayed Phase Complete Response (CR) Rate | 24 - 120 Hours | Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data. | percentage of participants | NUMBER |
| SECONDARY | Overall Complete Response Rate | 0 - 120 Hours | Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data. | percentage of participants | NUMBER |
| SECONDARY | Delayed Complete Control (CC) Rate | 24 - 120 Hours | Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data. | percentage of participants | NUMBER |
| SECONDARY | Overall Complete Control Rate | 0 - 120 Hours | Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data. | percentage of participants | NUMBER |
| SECONDARY | Rate of No Emetic Episodes | 0 - 120 Hours | Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delayed Phase Complete Response (CR) Rate | APF530 + Fosaprepitant + Dexamethasone | 64.7 | percentage of participants | ||
| Delayed Phase Complete Response (CR) Rate | Ondansetron + Fosaprepitant + Dexamethasone | 56.6 | percentage of participants | ||
| Overall Complete Response Rate | APF530 + Fosaprepitant + Dexamethasone | 58.4 | percentage of participants | ||
| Overall Complete Response Rate | Ondansetron + Fosaprepitant + Dexamethasone | 52.9 | percentage of participants | ||
| Delayed Complete Control (CC) Rate | APF530 + Fosaprepitant + Dexamethasone | 60.7 | percentage of participants | ||
| Delayed Complete Control (CC) Rate | Ondansetron + Fosaprepitant + Dexamethasone | 53.1 | percentage of participants | ||
| Overall Complete Control Rate | APF530 + Fosaprepitant + Dexamethasone | 54.7 | percentage of participants | ||
| Overall Complete Control Rate | Ondansetron + Fosaprepitant + Dexamethasone | 49.6 | percentage of participants | ||
| Rate of No Emetic Episodes | APF530 + Fosaprepitant + Dexamethasone | 82.2 | percentage of participants | ||
| Rate of No Emetic Episodes | Ondansetron + Fosaprepitant + Dexamethasone | 79.2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APF530 + Fosaprepitant + Dexamethasone | 471 | |
| Overall Study | STARTED | Ondansetron + Fosaprepitant + Dexamethasone | 471 | |
| Overall Study | Safety Population | APF530 + Fosaprepitant + Dexamethasone | 456 | |
| Overall Study | Safety Population | Ondansetron + Fosaprepitant + Dexamethasone | 459 | |
| Overall Study | Efficacy Population | APF530 + Fosaprepitant + Dexamethasone | 450 | |
| Overall Study | Efficacy Population | Ondansetron + Fosaprepitant + Dexamethasone | 452 | |
| Overall Study | COMPLETED | APF530 + Fosaprepitant + Dexamethasone | 445 | |
| Overall Study | COMPLETED | Ondansetron + Fosaprepitant + Dexamethasone | 446 | |
| Overall Study | NOT COMPLETED | APF530 + Fosaprepitant + Dexamethasone | 26 | |
| Overall Study | NOT COMPLETED | Ondansetron + Fosaprepitant + Dexamethasone | 25 |
Source ClinicalTrials.gov
Adverse events118
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 | Neutropenia | Blood and lymphatic system disorders | APF530 + Fosaprepitant + Dexamethasone | 26 | 456 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ondansetron + Fosaprepitant + Dexamethasone | 30 | 459 | |
| other | Constipation | Gastrointestinal disorders | APF530 + Fosaprepitant + Dexamethasone | 99 | 456 | |
| other | Constipation | Gastrointestinal disorders | Ondansetron + Fosaprepitant + Dexamethasone | 70 | 459 | |
| other | Diarrhea | Gastrointestinal disorders | APF530 + Fosaprepitant + Dexamethasone | 39 | 456 | |
| other | Diarrhea | Gastrointestinal disorders | Ondansetron + Fosaprepitant + Dexamethasone | 35 | 459 | |
| other | Dyspepsia | Gastrointestinal disorders | APF530 + Fosaprepitant + Dexamethasone | 27 | 456 | |
| other | Dyspepsia | Gastrointestinal disorders | Ondansetron + Fosaprepitant + Dexamethasone | 32 | 459 | |
| other | Nausea | Gastrointestinal disorders | APF530 + Fosaprepitant + Dexamethasone | 75 | 456 | |
| other | Nausea | Gastrointestinal disorders | Ondansetron + Fosaprepitant + Dexamethasone | 71 | 459 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APF530 + Fosaprepitant + Dexamethasone | ||
| Total, all-cause mortality | Ondansetron + Fosaprepitant + Dexamethasone | ||
| Total, other adverse events | APF530 + Fosaprepitant + Dexamethasone | 411 | 456 |
| Total, other adverse events | Ondansetron + Fosaprepitant + Dexamethasone | 407 | 459 |
| Total, serious adverse events | APF530 + Fosaprepitant + Dexamethasone | 42 | 456 |
| Total, serious adverse events | Ondansetron + Fosaprepitant + Dexamethasone | 28 | 459 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26997579 | RESULT |
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 |
|---|
| APF530 + Fosaprepitant + Dexamethasone vs Ondansetron + Fosaprepitant + 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/NCT02106494
GET https://conductscience.org/api/trials/v1/NCT02106494/events?page=2