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
- 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.
- 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
- 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
- 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.
PROJECTED ACCRUAL: A total of 1,338 patients will be accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Proportion of patients with complete response (CR) during acute phase (0-24 hours) after administration of chemotherapy course 1
John Barr, PhD
A.P. Pharma, Inc.
United States: Food and Drug Administration
|MultiCare Regional Cancer Center at Tacoma General Hospital||Tacoma, Washington 98405|
|Veterans Affairs Medical Center - Buffalo||Buffalo, New York 14215|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|McDowell Cancer Center at Akron General Medical Center||Akron, Ohio 44307|
|Mary Babb Randolph Cancer Center at West Virginia University Hospitals||Morgantown, West Virginia 26506|
|Northern Michigan Hospital||Petoskey, Michigan 49770|
|Regional Cancer Center at Singing River Hospital||Pascagoula, Mississippi 39581|
|Eastern Connecticut Hematology and Oncology Associates||Norwich, Connecticut 06360|
|MedCentral - Mansfield Hospital||Mansfield, Ohio 44903|
|Providence Hospital||Washington, District of Columbia 20017|
|Arizona Clinical Research Center, Incorporated||Tucson, Arizona 85715|
|Kenmar Research Institute||Los Angeles, California 90057|
|Mercy Medical Center||Baltimore, Maryland 21202|
|Kentuckiana Cancer Institute, PLLC||Louisville, Kentucky 40202|
|Falck Cancer Center at Arnot Ogden Medical Center||Elmira, New York 14905|
|Pacific Cancer Medical Center, Incorporated||Anaheim, California 92801|
|Gabrail Cancer Center - Canton Office||Canton, Ohio 44718|
|Cancer Center of Indiana||New Albany, Indiana 47150|
|Medical Center Vincennes||Vincennes, Indiana 47591|
|Southbay Oncology / Hematology Medical Group||Campbell, California 95008|
|Center for Cancer and Blood Disorders at Suburban Hospital||Bethesda, Maryland 20817|
|Virginia Oncology Care, PC||Richlands, Virginia 24641|
|Compassionate Cancer Care Medical Group Incorporated - Fountain Valley||Fountain Valley, California 92708|
|Signal Point Hematology Oncology Incorporated||Middletown, Ohio 45042|
|Kansas City Cancer Centers - South||Kansas City, Missouri 64131|
|Pottsville Cancer Clinic||Pottsville, Pennsylvania 17901|
|Columbus Clinic, PC||Columbus, Georgia 31901|
|Anniston Oncology, PC||Anniston, Alabama 36207|
|Palo Verde Hematology Oncology - Glendale||Glendale, Arizona 85304|
|Compassionate Cancer Care Medical Group Incorporated - Corona||Corona, California 92882|
|Advanced Research Management Services, Incorporated||Los Angeles, California 90057|
|Medical Oncology Care Associates - Orange||Orange, California 92868|
|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|
|Clintell, Incorporated||Skokie, Illinois 60077|
|Investigative Clinical Research, LLC||Indianapolis, Indiana 46254|
|Family Medicine of Vincennes Clinical Trial Center||Vincennes, Indiana 47591|
|Kentucky Cancer Clinic - Hazard||Hazard, Kentucky 41701|
|Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center||Lewiston, Maine 04240|
|Center for Clinical Research at Washington County Hospital||Hagerstown, Maryland 21740|
|Star Hematology & Oncology||Phillipsburg, New Jersey 08865|
|Hudson Valley Hematology-Oncology Associates - Poughkeepsie||Poughkeepsie, New York 12601|
|Comprehensive Cancer Center at Pardee Hospital||Hendersonville, North Carolina 28791|
|Boice Willis Clinic, PA||Rocky Mount, North Carolina 27804|
|Eastern North Carolina Medical Group, PLLC||Rocky Mount, North Carolina 27804|
|Gabrail Cancer Center - Dover Office||Dover, Ohio 44622|
|Cancer Treatment Centers of America at Southwestern Regional Medical Center||Tulsa, Oklahoma 74133-4564|
|Charleston Hematology Oncology Associates, PA||Charleston, South Carolina 29403|
|Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont Hospital||Beaumont, Texas 77701|
|Texas Cancer Clinic||San Antonio, Texas 78240|
|Cancer Outreach Associates - Abingdon||Abingdon, Virginia 24211|
|Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center||Lacey, Washington 98503|