An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
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ClinicalTrials.gov Identifier: NCT01339260 |
Recruitment Status :
Completed
First Posted : April 20, 2011
Results First Posted : November 26, 2014
Last Update Posted : November 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-Induced Nausea and Vomiting | Drug: Netupitant and Palonosetron Drug: Palonosetron Drug: Dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1455 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Netupitant and Palonosetron+dexamethasone-cycle 1
Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
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Drug: Netupitant and Palonosetron Drug: Dexamethasone |
Active Comparator: Palonosetron+dexamethasone-cycle 1
Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
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Drug: Palonosetron Drug: Dexamethasone |
Experimental: Netupitant and Palonosetron+dexamethasone-multicycle extension
Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
|
Drug: Netupitant and Palonosetron Drug: Dexamethasone |
Active Comparator: Palonosetron+dexamethasone-multicycle extension
Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
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Drug: Palonosetron Drug: Dexamethasone |
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1 [ Time Frame: 25-120 hours ]
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1 [ Time Frame: 0-24 hours ]
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1 [ Time Frame: 0-120 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- Eastern Cooperative Oncology Group (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 central nervous system (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 a neurokin-1 (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 cytocrome P450 3A4 (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) New York Heart Association (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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339260

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Helsinn Healthcare SA |
ClinicalTrials.gov Identifier: | NCT01339260 History of Changes |
Other Study ID Numbers: |
NETU-08-18 |
First Posted: | April 20, 2011 Key Record Dates |
Results First Posted: | November 26, 2014 |
Last Update Posted: | November 26, 2014 |
Last Verified: | November 2014 |
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone Dexamethasone acetate Palonosetron BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin 5-HT3 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |