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New shot could stop chemo sickness in its tracks

NCT ID NCT00343460

Symptom relief Sponsor: Heron Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested a drug called APF530, given as a shot, to prevent nausea and vomiting caused by chemotherapy. Over 1,400 cancer patients took part, comparing APF530 with the standard drug Aloxi. The goal was to see if APF530 could keep patients from vomiting or needing rescue medicine during the first day and the following days 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 drug given as a shot under the skin)
What this could lead to
If it works, this could give cancer patients a new option to prevent nausea and vomiting during chemotherapy, improving their quality of life.
What could go wrong
This is a completed phase 3 trial, but results may not show a clear advantage over the existing drug Aloxi. The benefit may be modest and not apply to all chemotherapy types.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,428 people

The number who actually took part.

Start date

Jun 2006

Finished

Feb 2009

Lead sponsor

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

18 to 120 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant disease * No head and neck cancer or upper gastrointestinal cancer * Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses) * Chemotherapy administration ≤ 4 hours * Duration of each course ≤ 28 days * Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm * Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment * No greater than mild nausea or any vomiting within 24 hours before beginning study treatment PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics * QTc interval ≤ 500 ms * No cardiac abnormality predisposing the patient to arrhythmia * No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation * No recent history (i.e., ≤ 1 year) of alcohol or drug abuse * No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment * More than 7 days since prior chemotherapy * More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications) * More than 7 days since prior antinausea medications * More than 30 days since prior treatment on an investigational trial * No other concurrent corticosteroids or dexamethasone at a different dose than study treatment * No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications

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Conditions

The condition(s) this trial relates to.

cancer Nausea Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nausea and vomiting Unspecified adult solid tumor, protocol specific

Contacts and locations

Locations

  • Advanced Research Management Services, Incorporated

    Los Angeles, California, 90057, United States

  • Anniston Oncology, PC

    Anniston, Alabama, 36207, United States

  • Arizona Clinical Research Center, Incorporated

    Tucson, Arizona, 85715, United States

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • Boice Willis Clinic, PA

    Rocky Mount, North Carolina, 27804, United States

  • Cancer Center of Indiana

    New Albany, Indiana, 47150, United States

  • Cancer Outreach Associates - Abingdon

    Abingdon, Virginia, 24211, United States

  • Cancer Treatment Centers of America at Southwestern Regional Medical Center

    Tulsa, Oklahoma, 74133-4564, United States

  • Center for Cancer and Blood Disorders at Suburban Hospital

    Bethesda, Maryland, 20817, United States

  • Center for Clinical Research at Washington County Hospital

    Hagerstown, Maryland, 21740, United States

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29403, United States

  • Clintell, Incorporated

    Skokie, Illinois, 60077, United States

  • Columbus Clinic, PC

    Columbus, Georgia, 31901, United States

  • Compassionate Cancer Care Medical Group Incorporated - Corona

    Corona, California, 92882, United States

  • Compassionate Cancer Care Medical Group Incorporated - Fountain Valley

    Fountain Valley, California, 92708, United States

  • Comprehensive Cancer Center at Pardee Hospital

    Hendersonville, North Carolina, 28791, United States

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Eastern North Carolina Medical Group, PLLC

    Rocky Mount, North Carolina, 27804, United States

  • Falck Cancer Center at Arnot Ogden Medical Center

    Elmira, New York, 14905, United States

  • Family Medicine of Vincennes Clinical Trial Center

    Vincennes, Indiana, 47591, United States

  • Gabrail Cancer Center - Canton Office

    Canton, Ohio, 44718, United States

  • Gabrail Cancer Center - Dover Office

    Dover, Ohio, 44622, United States

  • Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center

    Lewiston, Maine, 04240, United States

  • Hudson Valley Hematology-Oncology Associates - Poughkeepsie

    Poughkeepsie, New York, 12601, United States

  • Innovative Medical Research of South Florida, Incorporated

    North Miami Beach, Florida, 33179-4709, United States

  • Investigative Clinical Research, LLC

    Indianapolis, Indiana, 46254, United States

  • Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont Hospital

    Beaumont, Texas, 77701, United States

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131, United States

  • Kenmar Research Institute

    Los Angeles, California, 90057, United States

  • Kentuckiana Cancer Institute, PLLC

    Louisville, Kentucky, 40202, United States

  • Kentucky Cancer Clinic - Hazard

    Hazard, Kentucky, 41701, United States

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300, United States

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44302, United States

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903, United States

  • Medical Center Vincennes

    Vincennes, Indiana, 47591, United States

  • Medical Oncology Care Associates - Orange

    Orange, California, 92868, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202-2165, United States

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405, United States

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770, United States

  • Pacific Cancer Medical Center, Incorporated

    Anaheim, California, 92801, United States

  • Palo Verde Hematology Oncology - Glendale

    Glendale, Arizona, 85304, United States

  • Pasco Pinellas Cancer Center - New Port Richey

    New Port Richey, Florida, 34689, United States

  • Pottsville Cancer Clinic

    Pottsville, Pennsylvania, 17901, United States

  • Providence Hospital

    Washington D.C., District of Columbia, 20017, United States

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581, United States

  • Signal Point Hematology Oncology Incorporated

    Middletown, Ohio, 45042, United States

  • Southbay Oncology / Hematology Medical Group

    Campbell, California, 95008, United States

  • Star Hematology & Oncology

    Phillipsburg, New Jersey, 08865, United States

  • Texas Cancer Clinic

    San Antonio, Texas, 78240, United States

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215, United States

  • Virginia Oncology Care, PC

    Richlands, Virginia, 24641, United States

  • Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center

    Lacey, Washington, 98503, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.