APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

NCT00343460 | Completed Phase 3 Results

• 2 other identifiers: C2006-01APPA-C2006-01
• Study Type: interventional
• Target: 1,428
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  0-120 Hours

• Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1

  0-120 Hours

• Number of Emetic Episodes

  Days 1-5

• Time to First Treatment Failure

  0-120 Hours

• First and Overall Use of Rescue Medication

  0-120 Hours

Study Arms (3)

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.

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.

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.

Drug: APF530; Drug: dexamethasone; Other: placebo

Interventions

APF530 DRUG

Given subcutanously

Arm II; Arm III

dexamethasone DRUG

Given IV and orally

Arm I; Arm II; Arm III

placebo OTHER

Given subcutanously or IV

Arm I; Arm II; Arm III

Palonosetron Hydrochloride DRUG

Given IV

Arm I

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Heron Therapeutics: lead

Study Sites (52)

Anniston Oncology, PC

Anniston, Alabama, 36207, United States

Location

Palo Verde Hematology Oncology - Glendale

Glendale, Arizona, 85304, United States

Location

Arizona Clinical Research Center, Incorporated

Tucson, Arizona, 85715, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Pacific Cancer Medical Center, Incorporated

Anaheim, California, 92801, United States

Location

Southbay Oncology / Hematology Medical Group

Campbell, California, 95008, United States

Location

Compassionate Cancer Care Medical Group Incorporated - Corona

Corona, California, 92882, United States

Location

Compassionate Cancer Care Medical Group Incorporated - Fountain Valley

Fountain Valley, California, 92708, United States

Location

Advanced Research Management Services, Incorporated

Los Angeles, California, 90057, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Medical Oncology Care Associates - Orange

Orange, California, 92868, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Providence Hospital

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

Location

Pasco Pinellas Cancer Center - New Port Richey

New Port Richey, Florida, 34689, United States

Location

Innovative Medical Research of South Florida, Incorporated

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

Location

Columbus Clinic, PC

Columbus, Georgia, 31901, United States

Location

Clintell, Incorporated

Skokie, Illinois, 60077, United States

Location

Investigative Clinical Research, LLC

Indianapolis, Indiana, 46254, United States

Location

Cancer Center of Indiana

New Albany, Indiana, 47150, United States

Location

Family Medicine of Vincennes Clinical Trial Center

Vincennes, Indiana, 47591, United States

Location

Medical Center Vincennes

Vincennes, Indiana, 47591, United States

Location

Kentucky Cancer Clinic - Hazard

Hazard, Kentucky, 41701, United States

Location

Kentuckiana Cancer Institute, PLLC

Louisville, Kentucky, 40202, United States

Location

Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center

Lewiston, Maine, 04240, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202-2165, United States

Location

Center for Cancer and Blood Disorders at Suburban Hospital

Bethesda, Maryland, 20817, United States

Location

Center for Clinical Research at Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Star Hematology & Oncology

Phillipsburg, New Jersey, 08865, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Falck Cancer Center at Arnot Ogden Medical Center

Elmira, New York, 14905, United States

Location

Hudson Valley Hematology-Oncology Associates - Poughkeepsie

Poughkeepsie, New York, 12601, United States

Location

Comprehensive Cancer Center at Pardee Hospital

Hendersonville, North Carolina, 28791, United States

Location

Boice Willis Clinic, PA

Rocky Mount, North Carolina, 27804, United States

Location

Eastern North Carolina Medical Group, PLLC

Rocky Mount, North Carolina, 27804, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Gabrail Cancer Center - Canton Office

Canton, Ohio, 44718, United States

Location

Gabrail Cancer Center - Dover Office

Dover, Ohio, 44622, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Signal Point Hematology Oncology Incorporated

Middletown, Ohio, 45042, United States

Location

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133-4564, United States

Location

Pottsville Cancer Clinic

Pottsville, Pennsylvania, 17901, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29403, United States

Location

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

Beaumont, Texas, 77701, United States

Location

Texas Cancer Clinic

San Antonio, Texas, 78240, United States

Location

Cancer Outreach Associates - Abingdon

Abingdon, Virginia, 24211, United States

Location

Virginia Oncology Care, PC

Richlands, Virginia, 24641, United States

Location

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

Lacey, Washington, 98503, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Related Publications (2)

• 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.

  PMID: 26921245 DERIVED

• Raftopoulos 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.

  PMID: 26289588 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Granisetron; Dexamethasone; Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Quinuclidines; Isoquinolines

Results Point of Contact

• Title: Tricia Mulford
• Organization: Heron Therapeutics

tmulford@herontx.com

760-622-3709

Study Officials

• John Barr, PhD

  Heron Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: June 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2009
• Last Updated: March 2, 2026
• Results First Posted: December 28, 2016

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (52)