E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with neoplasia malignant. |
Pazienti con neoplasia maligna. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10010023 |
E.1.2 | Term | Colorectal neoplasms malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Treatment of the neurotoxicity from Oxaliplatino in patients with neoplasia malignant. |
Trattamento della neurotossicita' da Oxaliplatino in pazienti con neoplasia maligna. |
|
E.2.2 | Secondary objectives of the trial |
Appraisal of eventual therapeutic interferences. |
Valutazione di eventuali interferenze terapeutiche. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with istological or cytological diagnosis of neoplasia malignant. Presence of measurable and/or valued disease according to criteria RECIST. Age comprised between 18 and 75 years. Performance status => 60 sec. Karnofsky. Expectation of advanced life to 3 months. Adapted reservoir medullary. Adapted hepatic, renal and cardiac functionality. Informed consent written. |
Pazienti con diagnosi istologica o citologica di neoplasia maligna.
Presenza di malattia misurabile e/o valutabile secondo criteri RECIST.
Eta' compresa tra 18 e 75 anni.
Performance status => 60 sec. Karnofsky.
Aspettativa di vita superiore a 3 mesi.
Adeguata riserva midollare.
Adeguata funzionalita' epatica, renale e cardiaca.
Consenso informato scritto. |
|
E.4 | Principal exclusion criteria |
Previous chemotherapy with neurotoxic drugs. Presence of cerebral metastases. Carcinomatosa meningitis. Fibrous interstitial. Interstitial pneumonia. Cardiac lack of balance congestizio or strict arrhythmy or recent coronaric ischemica disease. Women in pregnancy or breast-feeding. Patients with infections in active or not controlled phase, or with known infection HIV. Other concomitant pathologies that contraindicate drugs in study to judgment of the clinician. Inability to supply an informed consent. Impossibility to guarantee the follow-up. |
Precedente chemioterapia con farmaci neurotossici.
Presenza di metastasi cerebrali.
Meningite carcinomatosa.
Fibrosi interstiziale.
Polmonite interstiziale.
Scompenso cardiaco congestizio o aritmia severa o malattia ischemica coronarica recente.
Donne in gravidanza o allattamento.
Pazienti con infezioni in fase attiva o non controllata, o con conosciuta infezione HIV.
Altre patologie concomitanti che controindicano i farmaci in studio a giudizio del clinico.
Incapacita' a fornire un consenso informato.
Impossibilita' a garantire il follow-up. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Patients with neoplasia malignant. |
Pazienti con neoplasia maligna. |
|
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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 42 |
E.8.9.1 | In the Member State concerned days | 0 |