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A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Chemotherapy-Induced Nausea and Vomiting

Thank you

Trial Information

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy


Inclusion Criteria:



- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be
permitted.

- Scheduled to receive first course of an anthracycline and cyclophosphamide containing
moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid
malignant tumor: cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. doxorubicin (more
or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V.
epirubicin (more or equal to 60 mg/m2).

- If scheduled to receive chemotherapy agents of minimal to low emetogenic potential
they could be given on any day.

- ECOG Performance Status of 0, 1, or 2.

- Female patients of either non-childbearing potential or child-bearing potential with
a commitment to use contraceptive methods throughout the clinical trial

- Hematologic and metabolic status adequate for receiving a moderately emetogenic
regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver
enzymes, Serum Creatinine or Creatinine Clearance)

The following inclusion criteria must be checked prior inclusion at each cycle of the
Multiple-Cycle Extension:

- Participation in the study during the next cycle of chemotherapy is considered
appropriate by the investigator Satisfactory study compliance in the preceding cycle
of chemotherapy and related study procedures.

- Scheduled to receive the same chemotherapy regimen as cycle 1

- Adequate hematologic and metabolic status as defined for cycle 1

Exclusion Criteria:

- If female, pregnant or lactating.

- Current use of illicit drugs or current evidence of alcohol abuse.

- Scheduled to receive any highly emetogenic chemotherapy (HEC) from Day 1 to Day 5 or
moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed
MEC regimen.

- Received or is scheduled to receive radiation therapy to the abdomen or the pelvis
within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1.

- Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.

- Symptomatic primary or metastatic CNS malignancy.

- Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial
pressure, hypercalcemia, an active infection or any uncontrolled medical condition
(other than malignancy) that, in the opinion of the investigator, may confound the
results of the study, represent another potential etiology for emesis and nausea
(other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks
in administering the study drugs to the patient.

- Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or
dexamethasone.

- Previously received an NK1 receptor antagonist

- Participation in a clinical trial involving oral netupitant administered in
combination with palonosetron.

- Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is
scheduled to receive any investigational drug during the study.

- Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle
1.

- Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.

- Any medication with known or potential antiemetic activity within 24 hours prior to
Day 1 of cycle 1

- Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within
1 week prior to Day 1.

- Scheduled to receive any of the following CYP3A4 substrates: terfenadine, cisapride,
astemizole, pimozide.

- Scheduled to receive any CYP3A4 inducer or its intake within 4 weeks prior to Day 1.

- History or predisposition to cardiac conduction abnormalities, except for incomplete
right bundle branch block.

- History of risk factors for Torsade de Point (heart failure, hypokalemia, family
history of Long QT Syndrome).

- Severe cardiovascular diseases, including myocardial infarction within 3 months prior
to Day 1, unstable angina pectoris, significant valvular or pericardial disease,
history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) NYHA
class III-IV, and severe uncontrolled arterial hypertension.

- Any illness or condition that, in the opinion of the investigator, may confound the
results of the study or pose unwarranted risks in administering the investigational
product to the patient.

- Concurrent medical condition that would preclude administration of dexamethasone such
as systemic fungal infection or uncontrolled diabetes.

The following exclusion criteria must be checked prior inclusion at each cycle of the
Multiple-Cycle Extension:

- If female, pregnant or lactating

- Active infection or uncontrolled disease except for malignancy.

- Started any of the restricted medications.

- Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Proportion of patients with complete response (CR) defined as no emesis, no rescue medication, at cycle 1

Outcome Time Frame:

25-120 hours

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

NETU-08-18

NCT ID:

NCT01339260

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Nausea
  • Vomiting

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Northern Utah AssociatesOgden, Utah  84403
Salem Research Group, Inc.Winston Salem, North Carolina  27103
Welborn ClinicEvansville, Indiana  47714
Charleston Cancer CenterCharleston, South Carolina  29406
Cancer Specialists of South Texas, P.A.Corpus Christi, Texas  78412
Facey Medical FoundationMission Hills, California  91345
Northwest Medical SpecialtiesTacoma, Washington  98405
Baptist Cancer InstituteJacksonville, Florida  32207
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Palm Beach Institute of Hematology and OncologyBoynton Beach, Florida  33435
Fallon ClinicWorcester, Massachusetts  01605
Compassionate Cancer Care Medical GroupCorona, California  92882
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
Signal Point Clinical Research CenterMiddletown, Ohio  45042
Agajanian Institute of Oncology and HematologyWhittier, California  90602
Denver Health and Hospital AuthorityDenver, Colorado  80204
American Institute of ResearchWhittier, California  90603
Floyd Memorial Cancer Center of IndianaNew Albany, Indiana  47150
Anniston Oncology/Regional Medical CenterAnniston, Alabama  
Genesis Cancer CentreHot Spring, Arkansas  71913
Compassionate Cancer Centre Medical GroupFountain Valley, California  92708
North Shore Medical CenterHazard, Kentucky  
The John R Marsh Cancer CenterHagerstown, Maryland  
Tri-County Hematology and Oncolgy AssociatesCanton, Ohio  44718
Blue Ridge Medical SpecialistBristol, Tennessee  37620
University of Texas Health CenterTyler, Texas