PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron 0.50 mg compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The study aims to demonstrate that palonosetron 0.50 mg given orally is as effective and safe as palonosetron 0.25 mg given intravenously to prevent nausea and vomiting in the first 24 hours after administration of one cycle of highly emetogenic cancer chemotherapy
- Conditions
- ausea and vomiting in cancer patients receiving highly emetogenic cisplatin-based chemotherapyMedDRA version: 14.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022223-29-DE
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
1.Signed written informed consent; 2.Male or female patient greater or equal than 18 years of age; 3. Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted; 4.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 greater or equal than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents; 5.If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential (see Appendix 3, Emetogenic Levels of Intravenous Antineoplastic Agents according to MASCC/ESMO guidelines) are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion; 6.If scheduled to receive chemotherapy agents of minimal to low emetogenic potential (Appendix 3), they are to be given on Day 1 following cisplatin or on any subsequent study day; 7.ECOG Performance Status of 0, 1, or 2 (Appendix 4); 8.Female patients of either: a.non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as 12 consecutive months of amenorrhea). In addition, postmenopausal definition has to be confirmed by consistent age and/or Follicle-Stimulating Hormone (FSH) levels), b.child-bearing potential with a negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product at Day 1 and with a commitment to consistent and correct use throughout the clinical trial of one of the following contraceptive methods: - whose male partner is sterile prior to the female patient’s entry into the study and is the sole sexual partner, - using double-barrier method of contraception consisting of spermicide with either condom or diaphragm, also if taking any oral contraceptive, for a period after the trial to account for a potential drug interaction (minimum four weeks), - with intrauterine device (IUD), - with complete abstinence from intercourse for two weeks before exposure to the investigational product and throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of fourteen days); should patients become sexually active during the period described above, they must agree to follow an acceptable method of birth control, as described above; 9.Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen and fulfillment of the following criteria: a)Total Neutrophils greater or equal than 1500/mm3 (Standard units: greater or equal than 1.5 x 10^9/L) - b)Platelets greater or equal than 100,000/mm3 (Standard units: greater or equal than 100.0 x 10^9/L) - c)Bilirubin less or equal than 1.5 x Upper Limit of Normal (ULN) - d)Liver enzymes: Without known liver metastases, Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) less or equal than 2.5 x Upper Limit of Normal (ULN) - With known liver metastases, AST and/or ALT less or equal than 5.0 x Upper Limit of Normal (ULN) - e)Serum Creatinine less or equal than 1.5 mg/dL (Standard units: less or equal than 132.6 microMOL/L) or Creatinine Clearance greater or equal than 60 mL/min; 10.If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of th
1.If female, pregnant or lactating; 2.Current use of illicit drugs or current evidence of alcohol abuse; 3.Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC (Appendix 3) from Day 2 to Day 5 following cisplatin administration; 4.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; 5.Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day 1; 6. Symptomatic primary or metastatic CNS malignancy; 7.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; 8.Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone; 9.Participation in a clinical trial involving palonosetron; 10.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. 11.Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of less or equal than 10 mg of prednisone daily or its equivalent are permitted; 12.Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy; 13.Any medication with known or potential antiemetic activity within 24 hours prior to Day 1, including: - 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron, palonosetron), - NK-1 receptor antagonists (e.g., aprepitant or any other new drug of this class), - benzamides (e.g., metoclopramide, alizapride), - phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine), - benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1), - butyrophenones (e.g., haloperidol, droperidol), - anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide), - antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorphenhyramine), except for prophylactic use for taxane therapy domperidone, - mirtazapine, - olanzapine, - prescribed cannabinoides (e.g., tetrahydrocannabinol or nabilone); 14.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; 15.Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method