E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with oxaliplatin-induced peripheral sensory neuropathy after having completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colorectal tumor |
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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 | LLT |
E.1.2 | Classification code | 10040039 |
E.1.2 | Term | Sensory peripheral neuropathy |
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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 |
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer |
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E.2.2 | Secondary objectives of the trial |
•To assess the effects of xaliproden on patient-reported outcomes using the FACT/GOG NTX-12 subscale.
•To assess the effect of xaliproden on the rate of at least partial recovery of grade ≥2 PSN at 6 months.
•To assess the effect of xaliproden on the time to complete recovery from PSN
•To evaluate the safety profile of xaliproden
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1/ Patient’s consent obtained, with Informed Consent Form signed and dated prior to protocol-specific procedures; 2/ Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization; 3/ Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0, 4/ Be at least 18 years of age; 5/ Have an ECOG Performance Status ≤ 2; 6/ Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 UNL; (b) serum creatinine <1.5xUNL; (c) HbA1c <7%; (d) neutrophils >1.5x109/L (e) platelets ≥50x109/L, (f) Serum D-dimer within normal limits.
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E.4 | Principal exclusion criteria |
1/ Pre-existing peripheral neuropathy prior to treatment with oxaliplatin 2/ Receiving any further anti-cancer treatment 3/ History of any recent (≤ 1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism 4/ Unstable cardiac disease. 5/ History of significant neurological or psychiatric disorders including dementia or seizures, 6/ Active uncontrolled infection 7/ Active disseminated intravascular coagulation 8/ Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; 9/ Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed. 10/ Concurrent treatment with any other experimental drugs. 11/ Pregnant or breast-feeding women; 12/ Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential. 13/ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessemnt of neurological sensory, as graded by the investigator using the NCI-CTCAE (version 3.0). |
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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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |