E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
preventing chemotherapy-induced nausea and vomiting in untreated patients with aggressive Non Hodgkins Lymphomas who underwent moderately emetogenic chemotherapy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028817 |
E.1.2 | Term | Nausea and vomiting symptoms |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary end point is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the whole study period (the first 5 days following administration of the first cycle of chemotherapy; 0-120 h). |
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E.2.2 | Secondary objectives of the trial |
evaluated during the Acute Phase (within the first 24 h after chemotherapy) and during the Delayed Phase (24-120 h) over the whole study period, include the following: the rate of Complete Response; the rate of Complete Control (defined as no emetic episode, and no need for rescue medication, with a maximum grade of mild nausea); number of emetic episodes; presence of nausea graded according to Likert scale; time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS); and safety. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Male or female, ³ 18 years of age; · Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification); · Patients candidates to a initial chemotherapy treatment; · ECOG performance status of 0-1; · Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification reported in the Appendix 2) on Day 1; · Written informed consent; · Female of childbearing potential must be using reliable contraceptive measures; · Acceptable hepatic function (£2 times the upper limit of normal for liver transaminases) and renal function (creatinine <1.5 times the upper limit of normal); · Willing and able to complete the patient diary. |
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E.4 | Principal exclusion criteria |
· Highly emetogenic chemotherapy (containing cisplatin, mechloretamine, streptozotocin, cyclophosphamide ³1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification reported in the Appendix 3); · Diagnosis of Hodgkins Disease or Leukemia; · Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation; · Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days; · Have received any investigational drugs within 30 days before study entry; · Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation); · Prior treatment with Palonosetron; · Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity; · Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase; · Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis; · Clinically relevant electrolyte abnormalities; · Have a known hypersensitivity to 5HT3 receptor antagonists; · Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy; · Female patients who are pregnant or breast feeding; · Inability to understand or cooperate with the study procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
to evaluate the efficacy and safety of a single dose of Palonosetron IV in preventing chemotherapy-induced nausea and vomiting (CINV) induced by moderately emetogenic chemotherapy agents used for the treatment of aggressive Non Hodgkins Lymphomas (NHL) (REAL classification). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |