New shot may beat standard pill for chemo nausea
NCT ID NCT02106494
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tested whether a new drug called APF530, given as a shot under the skin, works better than the standard drug ondansetron for preventing nausea and vomiting after strong chemotherapy. About 942 cancer patients took part. The study compared both drugs when combined with two other anti-nausea medicines. The main goal was to see if more people had no vomiting and didn't need extra rescue medication in the 24 to 120 hours after chemo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APF530 (a long-acting anti-nausea drug given as an injection under the skin)
- What this could lead to
- If it works, this could offer a more convenient, longer-lasting option to prevent nausea and vomiting after chemotherapy, reducing the need for rescue medications.
- What could go wrong
- This is a completed phase 3 trial, but results may not show a clear advantage over the standard treatment. Also, APF530 is a new formulation, so long-term safety data are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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942 people
The number who actually took part.
- Started
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Mar 2014
- Finished
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May 2015
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 87 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arizona Oncology Associates, PC-HAL
Phoenix, Arizona, 85016, United States
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Compassionate Cancer Medical Center
Riverside, California, 92501, United States
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Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
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North Shore Oncology
East Setauket, New York, 11733, United States
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Northern Indiana Research
Mishawaka, Indiana, 46545, United States
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Northern Indiana Research
South Bend, Indiana, 46804, United States
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The Oncology Institute of Hope and Innovation
Downey, California, 90241, United States
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