An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

Completed · Phase 3

Conditions studied: Chemotherapy-Induced Nausea and Vomiting

In brief

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.

Key facts

Study ID: NCT01363479
Run by: Helsinn Healthcare SA
People needed: 743
Starts: 2011-07-01
Expected to finish: 2012-11-01
Last updated by the study team: 2021-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents.
If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin 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 highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator.
If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator.

You may not qualify if…

If female, pregnant or lactating.
Current use of illicit drugs or current evidence of alcohol abuse.
Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration.
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.
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 conditions (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 (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
Participation in a clinical trial involving palonosetron.
Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 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. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent are permitted.
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

Where it is running

Compassionate Cancer Center — Corona, California, United States
Compassionate Cancer Centre Medical Group — Fountain Valley, California, United States
Facey Medical Group — Mission Hills, California, United States
Compassionate Cancer Care Medical Group — Riverside, California, United States
Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
Wellmont Medical Associates-Oncology and Hematology — Bristol, Rhode Island, United States
Charleston Hematology Oncology — Charleston, South Carolina, United States
Northern Utah Associates [Hematology/ Oncology] — Ogden, Utah, United States
Centro Oncológico Integral (COI) — Mar del Plata, Buenos Aires, Argentina
Clínica Universitaria Reina Fabiola — Córdoba, Argentina
Instituto Oncológico de Córdoba (IONC) — Córdoba, Argentina
Instituto Médico CER [Oncology] — Quilmes, Argentina
Sanatorio Parque — Rosario, Argentina
Centro Medico San Roque — San Miguel de Tucumán, Argentina
ISIS Clinica Especializada — Santa Fe, Argentina
MHAT Dr. Tota Venkova — Gabrovo, Bulgaria
Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department — Sofia, Bulgaria
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic — Sofia, Bulgaria
Specialised Hospital for Active treatment on Oncology — Sofia, Bulgaria
District Dispensery for Oncology Diseases with in-patient — Sofia, Bulgaria
Complex Oncology Centre — Stara Zagora, Bulgaria
Klinicki bolnicki centar [Oncology] — Osijek, Croatia
KBC Rijeka — Rijeka, Croatia
Opca bolnica Varazdin — Varaždin, Croatia
Genesis Cancer Centre — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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