E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
TOP2A gene amplified and oxaliplatin refractory metastatic colorectal cancer
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Progression-free survival |
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E.2.2 | Secondary objectives of the trial |
Overall survival
Response rate
Toxicity
Validation of plasma TIMP-1 and immunhistochemical TIMP-1 as biomarkers for anthracycline sensitivity/resistance
study the relationship between TOP2A and TOP1 gene amplifications |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically verified CRC with non-resectable mCRC
• Oxaliplatin resistant disease i.e. progression during or after oxaliplatin-based therapy
• Available FFPE tumor tissue blocks and TOP2A/CEN-17 ratio ≥ 1.5 in their malignant tumor cells in the primary tumor biopsy or in a biopsy from a metastatic lesion
• Measurable or non-measurable disease
• Age ≥ 18 years
• Performance status (WHO) of 0-2 and a life expectancy of at least 3 months
• Adequate haematological function defined as ANC ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l
• Adequate liver function defined as bilirubin ≤ 1,5 x UNL (upper normal limit)
• Written informed consent |
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E.4 | Principal exclusion criteria |
• Previous or synchronous malignancy, with the exception of adequately treated basal cell skin cancer or cervical cancer in situ
• Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives
• Pregnant or lactating women (in fertile women this is ensured according to guidelines of Danish Health and Medicines Authority)
• Known hypersensitivity to epirubicin
• Known heart disease
• Prior treatment of mCRC with a topoisomerase inhibitor e.g. irinotecan |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival |
et år |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Response rate
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seks måneder |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
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 | 2 |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |