Nausea and VomitingPhase 3NCT00343460
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
A Phase 3 study testing APF530, dexamethasone and Palonosetron Hydrochloride in people with Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, run by Heron Therapeutics at 52 sites in United States.
Trial summary
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- APF530, dexamethasone and Palonosetron Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,428 participants
- Where
- 52 sitesUnited States
- Study dates
- Jun 2006to Feb 2009
- Phase
- Phase 3
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Cancer Outreach Associates - Abingdon
Abingdon, Virginia, 24211
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44302
Pacific Cancer Medical Center, Incorporated
Anaheim, California, 92801
Anniston Oncology, PC
Anniston, Alabama, 36207
Mercy Medical Center
Baltimore, Maryland, 21202-2165
Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont Hospital
Beaumont, Texas, 77701
Center for Cancer and Blood Disorders at Suburban Hospital
Bethesda, Maryland, 20817
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Southbay Oncology / Hematology Medical Group
Campbell, California, 95008
Gabrail Cancer Center - Canton Office
Canton, Ohio, 44718
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403
Columbus Clinic, PC
Columbus, Georgia, 31901
Compassionate Cancer Care Medical Group Incorporated - Corona
Corona, California, 92882
Gabrail Cancer Center - Dover Office
Dover, Ohio, 44622
Falck Cancer Center at Arnot Ogden Medical Center
Elmira, New York, 14905
Compassionate Cancer Care Medical Group Incorporated - Fountain Valley
Fountain Valley, California, 92708
Palo Verde Hematology Oncology - Glendale
Glendale, Arizona, 85304
Center for Clinical Research at Washington County Hospital
Hagerstown, Maryland, 21740
Kentucky Cancer Clinic - Hazard
Hazard, Kentucky, 41701
Comprehensive Cancer Center at Pardee Hospital
Hendersonville, North Carolina, 28791
Investigative Clinical Research, LLC
Indianapolis, Indiana, 46254
Kansas City Cancer Centers - South
Kansas City, Missouri, 64131
Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center
Lacey, Washington, 98503
Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center
Lewiston, Maine, 04240
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Advanced Research Management Services, Incorporated
Los Angeles, California, 90057
Kenmar Research Institute
Los Angeles, California, 90057
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
MedCentral - Mansfield Hospital
Mansfield, Ohio, 44903
Signal Point Hematology Oncology Incorporated
Middletown, Ohio, 45042
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
Cancer Center of Indiana
New Albany, Indiana, 47150
Pasco Pinellas Cancer Center - New Port Richey
New Port Richey, Florida, 34689
Innovative Medical Research of South Florida, Incorporated
North Miami Beach, Florida, 33179-4709
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Medical Oncology Care Associates - Orange
Orange, California, 92868
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581
Northern Michigan Hospital
Petoskey, Michigan, 49770
Star Hematology & Oncology
Phillipsburg, New Jersey, 08865
Pottsville Cancer Clinic
Pottsville, Pennsylvania, 17901
Hudson Valley Hematology-Oncology Associates - Poughkeepsie
Poughkeepsie, New York, 12601
Virginia Oncology Care, PC
Richlands, Virginia, 24641
Boice Willis Clinic, PA
Rocky Mount, North Carolina, 27804
Eastern North Carolina Medical Group, PLLC
Rocky Mount, North Carolina, 27804
Texas Cancer Clinic
San Antonio, Texas, 78240
Clintell, Incorporated
Skokie, Illinois, 60077
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, 98405
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, 85715
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133-4564
Family Medicine of Vincennes Clinical Trial Center
Vincennes, Indiana, 47591
Medical Center Vincennes
Vincennes, Indiana, 47591
Providence Hospital
Washington D.C., District of Columbia, 20017
About this study
Official title: A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in combination with dexamethasone for prophylaxis of acute- or delayed-onset, chemotherapy-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer.
Secondary
- Evaluate the safety, tolerability, and efficacy of APF530, in terms of prevention of acute- and delayed-onset nausea and vomiting, in these patients.
- Gather the pharmacokinetics of APF530 in a subset of patients during chemotherapy course 1.
- Gather ECG data (using 24-hour Holter monitoring) in a subset of patients during chemotherapy course 1.
OUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are stratified according to emetogenicity of scheduled chemotherapy (moderate-risk [level 3 or 4] vs high-risk [level 5]). Patients are randomized to 1 of 3 treatment arms (I, II, and III). Patients who are randomized to receive palonosetron hydrochloride during chemotherapy course 1 (arm I) are then re-randomized to 1 of 2 treatment arms (II and III) after chemotherapy course 1 to receive treatment during chemotherapy courses 2-4.
Patients receive palonosetron hydrochloride or APF530 and/or placebo 30-60 minutes before the start of chemotherapy. Patients receive dexamethasone 30-90 minutes before the start of chemotherapy.
- Arm I: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.
- Arm II: Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
- Arm III: Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
A subset of patients undergo blood collection periodically during study for analysis of plasma APF530 concentration.
Quality of life is assessed on day 5 after completion of chemotherapy course 1.
After completion of study treatment, patients are followed at approximately 30 days.
- Being tested
- APF530, dexamethasone, Palonosetron Hydrochloride, placebo
- Keywords
- nausea and vomiting, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APF530Drug
Given subcutanously
dexamethasoneDrug
Given IV and orally
Palonosetron HydrochlorideDrug
Given IV
placeboOther
Given subcutanously or IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses. Receives: Drug: dexamethasone; Drug: Palonosetron Hydrochloride; Other: placebo |
| Arm II | Experimental | Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I. Receives: Drug: APF530; Drug: dexamethasone; Other: placebo |
| Arm III | Experimental | Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I. Receives: Drug: APF530; Drug: dexamethasone; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1
Complete Response is defined as no emetic episodes and no use of rescue medications
Measured: 0-24 Hours
Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
Complete Response is defined as no emetic episodes and no use of rescue medications
Measured: 24-120 Hours
Secondary outcomes (9)
Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1
Complete control is defined as complete response with no more than mild nausea.
Measured: 0-120 Hours
Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1
TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.
TR during delayed-onset phase is defined as Complete Response with no nausea during >24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.
Measured: 0-120 Hours
Number of Emetic Episodes
Number of Emetic Episodes - days 1-5
Measured: Days 1-5
Time to First Treatment Failure
Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration
Measured: 0-120 Hours
First and Overall Use of Rescue Medication
Measured: 0-120 Hours
Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)
Maximum severity of nausea, days 1-5
Measured: 0-120 Hours
Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses
Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles
Complete Response is defined as no emetic episodes and no use of rescue medications
Measured: 0-120 Hours
Quality of Life and the Impact of Nausea and Vomiting on Day 5
Functional Living Index
Measured: 5 days
Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1
Subject who were very satisfied on Day 1
Measured: 0- 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2008
- Study completionFeb 2009
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 (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Barr, PhD, Study chair, Heron Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343460
- Sponsor's protocol ID
- C2006-01
- Other IDs
- APPA-C2006-01
- Status last verified
- Feb 2026
- First submitted
- 22 Jun 2006
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boccia R, O'Boyle E, Cooper W. Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy. BMC Cancer. 2016 Feb 26;16:166. doi: 10.1186/s12885-016-2186-4.
PubMed 26921245Raftopoulos H, Boccia R, Cooper W, O'Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015 Sep;11(18):2541-51. doi: 10.2217/fon.15.185. Epub 2015 Aug 20.
PubMed 26289588