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A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

Phase 3
18 Years
Not Enrolling
Chemotherapy-Induced Nausea and Vomiting

Thank you

Trial Information

A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

Inclusion Criteria:

- Signed written informed consent.

- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is

- Diagnosed with a malignant tumor.

- If scheduled to receive repeated consecutive courses of chemotherapy, a single dose
of one or more of the following agents administered on Day 1 is allowed:

- Highly emetogenic chemotherapy: any I.V. dose of cisplatin, mechlorethamine,
streptozocin, cyclophosphamide more or equal to 1500 mg/m2, carmustine,

- Moderately emetogenic chemotherapy: any I.V. dose of oxaliplatin, carboplatin,
epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin,
cyclophosphamide I.V. (less than 1500 mg/m2), cytarabine I.V. (more than 1
g/m2), azacidine, alemtuzumab, bendamustine, or clofarabine.

- If scheduled to receive combination regimens, the most emetogenic agent is to be
given as first on Day 1 and the infusion must be completed within 6 hours.

- If scheduled to receive chemotherapy agents of minimal to low emetogenic potential,
they are to be given on Day 1 following the most emetogenic agent or on any
subsequent study 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)

Exclusion Criteria:

- If female, lactating or pregnant

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

- Scheduled to receive either 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).

- Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 to Day 5
following Day 1 chemotherapy administration.

- Active infection or uncontrolled disease except for malignancy that may pose
unwarranted risks in administering the study drugs to the patient.

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

- 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. Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg
of prednisone daily or its equivalent are permitted. Non-study drug dexamethasone as
pre-medication in patients scheduled to receive taxanes is allowed.

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

- 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 within 3 months prior to Day 1, including myocardial
infarction, unstable angina pectoris, significant valvular or pericardial disease,
history of ventricular tachycardia, symptomatic Congestive Heart Failure 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 for
4 days such as systemic fungal infection or uncontrolled diabetes.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients with Adverse Events

Outcome Description:

The duration of the study will vary depending on the number of chemotherapy cycles, the type of chemotherapeutic regimens and their frequency of administration

Outcome Time Frame:

Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Nausea
  • Vomiting



Providence St. Joseph Medical CenterBurbank, California  91505
South Texas Institute of CancerCorpus Christi, Texas  78405
Hematology Oncology Associates of RocklandNyack, New York  10960
American Institute of ResearchWhittier, California  90603
Northwest Alabama Cancer Center PCMuscle Shoals,, Alabama  35661
Tri-County Hematology & Oncology Associates, IncCanton, Ohio  44718
Hematology and Oncology Associates, Inc.Canton, Ohio  44708
Cancer Center at Memorial Hospital of RIPawtucket, Rhode Island  02860
Spartanburg Regional Health ServicesSpartanburg, South Carolina  29303
Department of Cytokine & Supportive Oncology - Unit 450Houston, Texas  77030