E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study subjects will be patients with operated colorectal cancer stage Duke C who are going through standard FOLFOX6 treatment (5-FU, calcium-levofoliate and oxaliplatin). The objective of the study is to investigate whether mangafodipir (Teslascan) can lower the incidence of FOLFOX6-related adverse events and increase quality of life. |
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MedDRA Classification |
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 present study is to find out whether pre-treatment with the compound mangafodipir lowers the frequency and/or severity of FOLFOX6-related haematological toxicity and neurosensory toxicity in patients operated for colorectal cancer in stage Duke C. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective will be to evaluate the frequency of other common adverse events, quality of life during FOLFOX6 regimen and number of patients requiring dose reduction. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Histologically proven colorectal cancer stage Duke C. 2) Patient over 18 years. 3) WHO performance status <1. 4) Adequate haematological function (Hb ≥ 100 g/L, ANC ≥ 2.0 x 109/L, platelets ≥ 150 x 109/L) 5) Adequate renal and hepatic functions: serum creatinine and total bilirubin ≤ 1.25 times upper normal limits (ASAT and ALAT ≤ 3 times upper normal limits) 6)Clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy 7)Use of adequate contraception 8)Written informed consent given (Appendix A)
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E.4 | Principal exclusion criteria |
1) Other tumour types than colorectal adenocarcinomas 2) Current severe neutropenia, leucopenia or thrombocytopenia 3) Severely reduced liver or renal function 4) Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn’s disease or ulcerative colitis 5) Current chronic diarrhoea 6) Contraindication for corticosteroid administration 7) History of prior serious allergic or pseudo-allergic reaction 8) Any other serious illness or medical condition 9) Symptomatic peripheral neuropathy ≥ grade 2 (Sanofi-NCI criteria) 10) Received mangafodipir ≤ 5 weeks before planned start of chemotherapy 11) Received any of the FOLFOX drugs ≤ 5 weeks planned start of chemotherapy 12) Any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study 13) Pregnant or nursing females 14) Patients (M/F) with reproductive potential not implementing adequate contraceptive measures 15)Pheochromocytoma
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points will be two of the most frequent toxic manifestations of FOLFOX6, namely neutropenia and neurosensory toxicity |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |