Chemotherapy-induced Nausea and VomitingPhase 3NCT02106494
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
A Phase 3 study testing APF530, Ondansetron and Fosaprepitant in people with Chemotherapy-induced Nausea and Vomiting, run by Heron Therapeutics at 7 sites in United States.
Trial summary
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in… Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- APF530, Ondansetron and Fosaprepitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 942 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment.
- Subjects must have histologically or cytologically confirmed malignant disease.
- Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guidelines for further details on the emetogenic classifications of chemotherapy agents for this study).
- A life expectancy > 6 months
- Subjects must be able to receive standardized doses of dexamethasone as required in the protocol for the prevention of emesis.
- Subjects must be characterized as having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Subjects must have adequate bone marrow, kidney, and liver function.
- Subjects must be able to swallow oral medications (pills) without difficulty.
- Subjects must be entering the first cycle of their current chemotherapy regimen.
- Subjects must be willing and able to comply with all testing and requirements defined in the protocol.
- Subjects must be able to provide voluntary, written, informed consent to participate in this study and must be able to fully understand the study requirements.
- Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study, using at least one form of contraception. It is recommended that females and female partners of male subjects remain adequately protected from conception during the study and for up to 1 year following study participation.
Who cannot join
- Subject has a known hypersensitivity to granisetron or any 5-HT3 receptor antagonist.
- Subject has a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of > 450 msec in men and > 470 msec in women on the screening ECG.
- Subject has PR > 240 msec, QRS > 110 msec, or a history of prolongation of QT interval.
- Subject has a family history of long QT syndrome.
- Subject has a history of cardiac disease, including congenital long QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, or chest pain or dyspnea on exertion.
- Subject has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia.
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- Subject has idiopathic cardiomyopathy, syncope, epilepsy, hypertrophic cardiomyopathy, or other clinically significant cardiac disease.
- Subject is pregnant or breast-feeding.
- Subject is planning to receive multiple-day chemotherapy.
- Subject has taken any of the following agents within 7 days prior to initiation of chemotherapy (the study): 5-HT3 receptor antagonists, phenothiazines, benzamides, domperidone, cannabinoids, or NK-1 receptor antagonist.
- Subject has taken any benzodiazepine within 1 day (24 hours) prior to initiation of chemotherapy (the study).
- Subject is scheduled to receive any other chemotherapeutic agent from Day 2 through Day 6.
- Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
- Subject has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study, except as premedication for chemotherapy (e.g., taxanes, pemetrexed).
- Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
- Subject has ongoing vomiting, retching, or nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
- Subject has vomited and/or has had dry heaves or retching within 24 hours prior to the start of HEC on Day 1.
- Subject is NOT able to swallow oral medications (pills) without difficulty.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
The Oncology Institute of Hope and Innovation
Downey, California, 90241
North Shore Oncology
East Setauket, New York, 11733
Northern Indiana Research
Mishawaka, Indiana, 46545
Arizona Oncology Associates, PC-HAL
Phoenix, Arizona, 85016
Compassionate Cancer Medical Center
Riverside, California, 92501
Northern Indiana Research
South Bend, Indiana, 46804
About this study
Official title: A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- APF530, Ondansetron, Ondansetron placebo, APF530 placebo, Fosaprepitant
- Keywords
- Highly emetogenic chemotherapy (HEC), Chemotherapy-Induced Nausea and Vomiting (CINV)
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APF530Drug
OndansetronDrug
Ondansetron placeboDrug
APF530 placeboDrug
FosaprepitantDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| APF530 500 mg SC | Experimental | APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC Receives: Drug: APF530; Drug: Ondansetron placebo; Drug: Fosaprepitant; Drug: Dexamethasone |
| ondansetron 0.15 mg/kg IV | Active comparator | Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 Receives: Drug: Ondansetron; Drug: APF530 placebo; Drug: Fosaprepitant; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Phase Complete Response (CR) Rate
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
Measured: 24 - 120 Hours
Secondary outcomes (4)
Overall Complete Response Rate
To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.
Measured: 0 - 120 Hours
Delayed Complete Control (CC) Rate
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.
Measured: 24 - 120 Hours
Overall Complete Control Rate
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.
Measured: 0 - 120 Hours
Rate of No Emetic Episodes
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.
Measured: 0 - 120 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Gelder, MD, Study director, Heron Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106494
- Sponsor's protocol ID
- C2013-01
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2014
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schnadig ID, Agajanian R, Dakhil C, Gabrail NY, Smith RE Jr, Taylor C, Wilks ST, Schwartzberg LS, Cooper W, Mosier MC, Payne JY, Klepper MJ, Vacirca JL. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016 Jun;12(12):1469-81. doi: 10.2217/fon-2016-0070. Epub 2016 Mar 21.
PubMed 26997579
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT02106494
- Acronym / sponsor ID
- C2013-01
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Highly emetogenic chemotherapy (HEC), Chemotherapy-Induced Nausea and Vomiting (CINV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APF530 500 mg SC | Experimental | Drug: APF530, Drug: Ondansetron placebo, Drug: Fosaprepitant, Drug: DexamethasoneAPF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC |
| ondansetron 0.15 mg/kg IV | Active comparator | Drug: Ondansetron, Drug: APF530 placebo, Drug: Fosaprepitant, Drug: DexamethasoneOndansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment.
- Subjects must have histologically or cytologically confirmed malignant disease.
- Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guidelines for further details on the emetogenic classifications of chemotherapy agents for this study).
- A life expectancy > 6 months
- Subjects must be able to receive standardized doses of dexamethasone as required in the protocol for the prevention of emesis.
Key exclusion criteria (18 listed)
- Subject has a known hypersensitivity to granisetron or any 5-HT3 receptor antagonist.
- Subject has a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of > 450 msec in men and > 470 msec in women on the screening ECG.
- Subject has PR > 240 msec, QRS > 110 msec, or a history of prolongation of QT interval.
- Subject has a family history of long QT syndrome.
- Subject has a history of cardiac disease, including congenital long QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, or chest pain or dyspnea on exertion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APF530 | Drug | APF530 500 mg SC |
| Ondansetron | Drug | ondansetron 0.15 mg/kg IV |
| Ondansetron placebo | Drug | APF530 500 mg SC |
| APF530 placebo | Drug | ondansetron 0.15 mg/kg IV |
| Fosaprepitant | Drug | APF530 500 mg SC, ondansetron 0.15 mg/kg IV |
| Dexamethasone | Drug | APF530 500 mg SC, ondansetron 0.15 mg/kg IV |
Primary outcome
Delayed Phase Complete Response (CR) Rate
Time frame: 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.
4 secondary outcomes
Overall Complete Response Rate
Time frame: 0 - 120 Hours
Delayed Complete Control (CC) Rate
Time frame: 24 - 120 Hours
Overall Complete Control Rate
Time frame: 0 - 120 Hours
Rate of No Emetic Episodes
Time frame: 0 - 120 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26997579Schnadig ID, Agajanian R, Dakhil C, Gabrail NY, Smith RE Jr, Taylor C, Wilks ST, Schwartzberg LS, Cooper W, Mosier MC, Payne JY, Klepper MJ, Vacirca JL. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016 Jun;12(12):1469-81. doi: 10.2217/fon-2016-0070. Epub 2016 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gelder, MD study director
Heron Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APF530, Ondansetron and Fosaprepitant in people with Chemotherapy-induced Nausea and Vomiting, run by Heron Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Phase Complete Response (CR) Rate (time frame: 24 - 120 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02106494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.