E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic, non-resectable and chemo-refractory colorectal cancer |
Metastatisk, ikke-resektabel og kemo-refraktær kolorektal-kræft |
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E.1.1.1 | Medical condition in easily understood language |
The purpose of this study is to evaluate the efficacy and tolerability of Lonsurf with or without bevacizumab in Caucasian patients with chemo-refractory metastatic colorectal adenocarcinoma. |
Formålet er at evaluere effekt og tolerabilitet af Lonsurf med eller uden bevacizumab til beh. af patienter med kemo-resistent kræft i tyktarm eller endetarm med spredning til andre dele af kroppen. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
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 |
Primary objective:
• Progression-free survival (PFS)
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E.2.2 | Secondary objectives of the trial |
Secondary objectives:
• Overall survival (OS)
• Response rate (RR) according to RECIST criteria version 1.1
• Toxicity
• Correlation between tumour markers and outcome
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥ 18 years.
• Histologically verified colorectal adenocarcinoma.
• Non-resectable mCRC.
• Measurable or non-measurable disease.
• Performance status (WHO) of 0-1 and a life expectancy of at least 3 months.
• Failure of previous (or intolerance to) fluoropyrimidines, irinotecan, oxaliplatin, cetuximab or panitumumab (only for RAS wild type); prior bevacizumab, aflibercept or regorafenib allowed but not mandatory.
• Adequate haematological function defined as neutrophils 1.5 x 109/l and platelets ≥ 100 x 109/l.
• Adequate organ function (bilirubin ≤ 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min.
• Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomisation. Male and female patients who have the potential to reproduce must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) during the study and for 6 months after the discontinuation of study medication.
• Has provided written informed consent prior to performance of any study procedure.
• Written informed consent must be obtained according to the local Ethics Committee requirements.
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E.4 | Principal exclusion criteria |
• Prior history of cancer, except cervix in situ carcinoma, in situ urothelial carcinoma or previously treated and cured skin basocellular, and any other cancer in complete remission for at least 2 years.
• Any other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
• Known allergy or intolerance to any of the drugs used (Lonsurf, bevacizumab).
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end-point:
• Progression-free survival (PFS)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The trial is expected to start right after the Danish Authorities approval of the protocol has been granted. Target recruitment period is estimated to be 18 months and follow-up period/end date is estimated to be 3 months after inclusion of last patient. |
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E.5.2 | Secondary end point(s) |
Secondary end-points:
*Overall survival (OS)
*Toxicity-profile
*Tumour markers (blood tests)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The trial is expected to start right after the Danish Authorities approval of the protocol has been granted. Target recruitment period is estimated to be 18 months and follow-up period/end date is estimated to be 3 months after inclusion of last patient. |
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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 | 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 | 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) | Yes |
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
| 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 | 3 |
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 | 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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LVLS - last visit last subject - with additional follow-up after 6 months. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |