TriangleNCT01339260 · CITED IN SOURCE DOCUMENTS
An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2014-11-26
NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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
- intervention Names
- Drug: Netupitant and Palonosetron
- Drug: Dexamethasone
- label
- Netupitant and Palonosetron+dexamethasone-cycle 1
- type
- EXPERIMENTAL
- description
- Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
- intervention Names
- Drug: Palonosetron
- Drug: Dexamethasone
- label
- Palonosetron+dexamethasone-cycle 1
- type
- ACTIVE_COMPARATOR
- description
- 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
- intervention Names
- Drug: Netupitant and Palonosetron
- Drug: Dexamethasone
- label
- Netupitant and Palonosetron+dexamethasone-multicycle extension
- type
- EXPERIMENTAL
- description
- Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
- intervention Names
- Drug: Palonosetron
- Drug: Dexamethasone
- label
- Palonosetron+dexamethasone-multicycle extension
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Netupitant and Palonosetron+dexamethasone-cycle 1
- Netupitant and Palonosetron+dexamethasone-multicycle extension
- name
- Netupitant and Palonosetron
- type
- DRUG
- arm Group Labels
- Palonosetron+dexamethasone-cycle 1
- Palonosetron+dexamethasone-multicycle extension
- name
- Palonosetron
- type
- DRUG
- arm Group Labels
- Netupitant and Palonosetron+dexamethasone-cycle 1
- Netupitant and Palonosetron+dexamethasone-multicycle extension
- Palonosetron+dexamethasone-cycle 1
- Palonosetron+dexamethasone-multicycle extension
- name
- Dexamethasone
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- PREVENTION
Enrollment
- count
- 1455
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
- time Frame
- 25-120 hours
- secondary Outcomes
- measure
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
- time Frame
- 0-24 hours
- measure
- Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
- time Frame
- 0-120 hours
Full study description
- brief Summary
- NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
- detailed Description
- NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. Study is organised in two phases: cycle-1 and a multi-cycle extension. Safety assessment is performed separately in cycle 1 (arm 1 and arm 2) and in multi-cycle extension (arm 3 and arm 4).
Source references
- references
- citation
- Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
- pmid
- 30968588
- type
- DERIVED
- citation
- Rugo HS, Rossi G, Rizzi G, Aapro M. Efficacy of NEPA (netupitant/palonosetron) across multiple cycles of chemotherapy in breast cancer patients: A subanalysis from two phase III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.
- pmid
- 28285236
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- Acute phase: 0 to 24 hours post-cisplatin treatment. 98.5 89.7 0.002 Overall Phase Overall: 0 to 120 hours post-cisplatin treatment. 89.6 76.5 0.003 Study 2 ( NCT01339260 ) In a multicenter, randomized, parallel, double-blind, active controlled, superiority trial, the efficacy and safety of a single oral dose of AKYNZEO was comp
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Preserved source evidence · Not medical advice