Single Dose, Randomized, Double-Blind, Parallel Group, Multicenter Study of Palonosetron 0.25 mg, 0.50 mg and 0.75 mg Administered by the Oral Route versus Palonosetron 0.25 mg IV for the Prevention of Moderately Emetogenic Chemotherapy-Induced Nausea and Vomiting in Patients with Cancer
- Conditions
- Moderately emetogenic chemotherapy induced nausea and vomiting
- Registration Number
- EUCTR2005-000137-37-CZ
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 640
1.Male or female, >/= 18 years of age
2.Histologically or cytologically confirmed malignant disease
3.Naïve or non-naïve to cancer chemotherapy (see Protocol Section 3.1 for definition)
4.If a patient is non-naïve, he/she must have experienced no more than mild nausea and no vomiting following any previous chemotherapy cycle.
5.A Karnofsky index of >/= 50%
6.Scheduled to receive a single intravenous dose of at least one of the following agents administered on Day 1:
•any dose of oxaliplatin, carboplatin, epirubicin, idarubicin, doxorubicin, ifosfamide, irinotecan or daunorubicin or
•cyclophosphamide <1500 mg/m2 or cytarabine >1g/m2.
7.Patient scheduled to receive the most emetogenic chemotherapeutic agent during a maximum of 4 hours
8.Written informed consent (with additional legal representative’s or parent’s consent if required).
9.If a patient has known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she may be enrolled in this study at the discretion of the Investigator
10.If a patient has a known history or predisposition to cardiac conduction interval abnormalities, including QTc, he/she may be enrolled in the study at the discretion of the Investigator
11.If a patient is female of childbearing potential, she must be using reliable contraceptive measures with a negative pregnancy test at the pretreatment (screening) visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Inability to understand or cooperate with the study procedures
2.Any investigational drugs within 30 days before the start of study treatment
3.Any drug with potential anti-emetic efficacy within 24 hours of the start of study treatment. Examples of these drugs are: 5 HT3 receptor antagonists, aprepitant, metoclopramide, phenothiazine anti-emetics (such as prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except triazolam or zolpidem used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid such as dexamethasone, hydrocortisone, methylprednisolone, and prednisone. Patients taking topical or inhaled steroids may be enrolled in the study.
4.Any antacid medication within 24 hours of the start of study treatment
5.Any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy
6.Treatment with US, EU or Mexican commercially available IV palonosetron 0.25 mg (Aloxi®; Onicit®) within two weeks prior to the start of study treatment.
7.Enrollment in a previous study with palonosetron
8.Ongoing vomiting from any organic etiology
9.Presence of a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication (prophylactic anticonvulsant medication for patients free of seizure activity is allowed)
10.Any moderately or highly emetogenic chemotherapy or radiotherapy received within 1 week prior to the start of the study treatment
11.Scheduled to receive:
•orally or intravenously: any dose of cisplatin, dacarbazine, streptozotocin, carmustine, mechlorethamine, hexamethylmelamine or procarbazine; or cyclophosphamide >/= 1500 mg/m2 during Days 1 to 5 of the study. See also Appendix F.
•radiotherapy of upper abdomen or cranium or total body irradiation during Days 1 to 5 of the study.
•Docetaxel, Paclitaxel or Pemetrexed on Day 1 in association with corticosteroids for the prevention of hypersensitivity reactions.
•any low-level emetogenic chemotherapeutic agent during Days 2 to 5, if this chemotherapy, in the investigators’ opinion, requires co-administration of antiemetics. Administration of low-level emetogenic chemotherapy without antiemetics is allowed on Days 2 to 5 (see also Appendix F).
12.Known contraindication to 5-HT3 receptor antagonists
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