E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peripheral neurophaty in cancer patients previously treated with taxanes- or platinum-based chemotherapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10027655 |
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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 main objective of the study is to evaluate the efficacy of ALC in reducing the intensity of taxanes- or platinum-induced sensory neuropathy in cancer patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate: - Motor item of NCI-CTC version 3.0 - ulnar, sural and common peroneal nerve conduction velocity (NCV); - symptoms/signs of peripheral damage; - vibration perception threshold; - total neuropathy score, TNS; - plasma NGF level.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Male and female age >/= 18 years; - Written informed consent; - Karnofsky > 60; - Life expectancy >/= 6 months; - Adequate organ functions defined as follows: - absolute neutrophil count >/= 1.0 *10^9 L - platelet count >/= 75.0 *10^9 L - serum creatinine level < 3 x UNL - alkaline phosphatase </=5 x UNL - taxanes- or platinum-induced sensory peripheral neuropathy grade 2 or 3, according to the sensory item of NCI-CTC version 3.0, at least 1 month after neurotoxic (taxanes or platinum-based) chemotherapy for cancer treatment discontinuation.
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E.4 | Principal exclusion criteria |
- Pre-existing neuropathies of different origin than those considered in this trial; - diabetes mellitus, insulin-dependent; - symptomatic brain metastases; - leptomeningeal involvement; - significant infective illness or active inflamed focus; - concomitant therapy with other neuroprotective agents (for details, see section 5.5 of the protocol); - any previous use of neuro-protectant drugs (such as sodium thiosulphate, glutathione, amifostine, gabapentin, lamotrigine, glutamic acid, ACTH analogues, neuronal growth factors, Vitamin E) if performed from the last chemotherapy administration, onwards; - any neurotoxic chemotherapy since one month prior to baseline; - predictable lack of patient’s co-operation; - pregnancy, nursing, or women of childbearing potential not using an effective method of birth control; - concomitant use of both platinum and taxane in the same line chemotherapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The sensory item of NCI-CTC version 3.0 December 12th, 2003 will be the primary endpoint. |
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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 | No |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | 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
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Last visit of the last patient |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |