Spots Global Cancer Trial Database for APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
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Trial Identification
Brief Title: APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
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
Study ID: NCT00343460
Study Description
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anniston Oncology, PC, Anniston, Alabama, United States
Palo Verde Hematology Oncology - Glendale, Glendale, Arizona, United States
Arizona Clinical Research Center, Incorporated, Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Incorporated, Anaheim, California, United States
Southbay Oncology / Hematology Medical Group, Campbell, California, United States
Compassionate Cancer Care Medical Group Incorporated - Corona, Corona, California, United States
Compassionate Cancer Care Medical Group Incorporated - Fountain Valley, Fountain Valley, California, United States
Advanced Research Management Services, Incorporated, Los Angeles, California, United States
Kenmar Research Institute, Los Angeles, California, United States
Medical Oncology Care Associates - Orange, Orange, California, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
Providence Hospital, Washington, District of Columbia, United States
Pasco Pinellas Cancer Center - New Port Richey, New Port Richey, Florida, United States
Innovative Medical Research of South Florida, Incorporated, North Miami Beach, Florida, United States
Columbus Clinic, PC, Columbus, Georgia, United States
Clintell, Incorporated, Skokie, Illinois, United States
Investigative Clinical Research, LLC, Indianapolis, Indiana, United States
Cancer Center of Indiana, New Albany, Indiana, United States
Family Medicine of Vincennes Clinical Trial Center, Vincennes, Indiana, United States
Medical Center Vincennes, Vincennes, Indiana, United States
Kentucky Cancer Clinic - Hazard, Hazard, Kentucky, United States
Kentuckiana Cancer Institute, PLLC, Louisville, Kentucky, United States
Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center, Lewiston, Maine, United States
Mercy Medical Center, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders at Suburban Hospital, Bethesda, Maryland, United States
Center for Clinical Research at Washington County Hospital, Hagerstown, Maryland, United States
Northern Michigan Hospital, Petoskey, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Kansas City Cancer Centers - South, Kansas City, Missouri, United States
Star Hematology & Oncology, Phillipsburg, New Jersey, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Falck Cancer Center at Arnot Ogden Medical Center, Elmira, New York, United States
Hudson Valley Hematology-Oncology Associates - Poughkeepsie, Poughkeepsie, New York, United States
Comprehensive Cancer Center at Pardee Hospital, Hendersonville, North Carolina, United States
Boice Willis Clinic, PA, Rocky Mount, North Carolina, United States
Eastern North Carolina Medical Group, PLLC, Rocky Mount, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Gabrail Cancer Center - Canton Office, Canton, Ohio, United States
Gabrail Cancer Center - Dover Office, Dover, Ohio, United States
MedCentral - Mansfield Hospital, Mansfield, Ohio, United States
Signal Point Hematology Oncology Incorporated, Middletown, Ohio, United States
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Tulsa, Oklahoma, United States
Pottsville Cancer Clinic, Pottsville, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont Hospital, Beaumont, Texas, United States
Texas Cancer Clinic, San Antonio, Texas, United States
Cancer Outreach Associates - Abingdon, Abingdon, Virginia, United States
Virginia Oncology Care, PC, Richlands, Virginia, United States
Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center, Lacey, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
Contact Details
Name: John Barr, PhD
Affiliation: Heron Therapeutics
Role: STUDY_CHAIR
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