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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

PROJECTED ACCRUAL: A total of 1,338 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Proportion of patients with complete response (CR) during acute phase (0-24 hours) after administration of chemotherapy course 1

Safety Issue:

No

Principal Investigator

John Barr, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

A.P. Pharma, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000489413

NCT ID:

NCT00343460

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting

Name

Location

MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
Northern Michigan HospitalPetoskey, Michigan  49770
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Providence HospitalWashington, District of Columbia  20017
Arizona Clinical Research Center, IncorporatedTucson, Arizona  85715
Kenmar Research InstituteLos Angeles, California  90057
Mercy Medical CenterBaltimore, Maryland  21202
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905
Pacific Cancer Medical Center, IncorporatedAnaheim, California  92801
Gabrail Cancer Center - Canton OfficeCanton, Ohio  44718
Cancer Center of IndianaNew Albany, Indiana  47150
Medical Center VincennesVincennes, Indiana  47591
Southbay Oncology / Hematology Medical GroupCampbell, California  95008
Center for Cancer and Blood Disorders at Suburban HospitalBethesda, Maryland  20817
Virginia Oncology Care, PCRichlands, Virginia  24641
Compassionate Cancer Care Medical Group Incorporated - Fountain ValleyFountain Valley, California  92708
Signal Point Hematology Oncology IncorporatedMiddletown, Ohio  45042
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Pottsville Cancer ClinicPottsville, Pennsylvania  17901
Columbus Clinic, PCColumbus, Georgia  31901
Anniston Oncology, PCAnniston, Alabama  36207
Palo Verde Hematology Oncology - GlendaleGlendale, Arizona  85304
Compassionate Cancer Care Medical Group Incorporated - CoronaCorona, California  92882
Advanced Research Management Services, IncorporatedLos Angeles, California  90057
Medical Oncology Care Associates - OrangeOrange, California  92868
Pasco Pinellas Cancer Center - New Port RicheyNew Port Richey, Florida  34689
Innovative Medical Research of South Florida, IncorporatedNorth Miami Beach, Florida  33179-4709
Clintell, IncorporatedSkokie, Illinois  60077
Investigative Clinical Research, LLCIndianapolis, Indiana  46254
Family Medicine of Vincennes Clinical Trial CenterVincennes, Indiana  47591
Kentucky Cancer Clinic - HazardHazard, Kentucky  41701
Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer CenterLewiston, Maine  04240
Center for Clinical Research at Washington County HospitalHagerstown, Maryland  21740
Star Hematology & OncologyPhillipsburg, New Jersey  08865
Hudson Valley Hematology-Oncology Associates - PoughkeepsiePoughkeepsie, New York  12601
Comprehensive Cancer Center at Pardee HospitalHendersonville, North Carolina  28791
Boice Willis Clinic, PARocky Mount, North Carolina  27804
Eastern North Carolina Medical Group, PLLCRocky Mount, North Carolina  27804
Gabrail Cancer Center - Dover OfficeDover, Ohio  44622
Cancer Treatment Centers of America at Southwestern Regional Medical CenterTulsa, Oklahoma  74133-4564
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont HospitalBeaumont, Texas  77701
Texas Cancer ClinicSan Antonio, Texas  78240
Cancer Outreach Associates - AbingdonAbingdon, Virginia  24211
Western Washington Oncology, Incorporated, PS at Western Washington Cancer CenterLacey, Washington  98503