E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Venous thrombosis in patients with cancer |
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E.1.1.1 | Medical condition in easily understood language |
Blood clots in veins in patients with cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate if apixaban is safe in the treatment of VT in cancer patients.
To evaluate if apixaban is effective in the treatment of VT in cancer patients.
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E.2.2 | Secondary objectives of the trial |
To evaluate if apixaban influence mortality in cancer patients with VT.
To identify risk factors for bleeding and recurrent VT in patients with VT and cancer.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 years
A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer.
Objectively verified VT
Informed consent
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E.4 | Principal exclusion criteria |
Anticoagulant therapy prior to trial entry for > 96 hours
Severe thrombocytopenia (platelets <50•109/L)
Severe renal failure – creatinine clearance <30 ml/min
The patients will be treated with catheter based thrombolysis for DVT or systemic thrombolysis for severe pulmonary embolism
Pregnancy or breastfeeding.
Childbearing potential without proper contraceptive measures
Drug abuse or mental disease that may interfere with treatment and follow-up.
Severe malabsorption so that oral treatment are expected to have reduced effect
Mechanical heart valves
Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the VT
Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis)
Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, vorikonazol or posakonazol) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint of safety: Rate of major or clinically relevant non-major bleeding after 6 months.
Primary endpoint of efficacy: Rate of recurrent objectively confirmed VT or death related to VT within 6 months.
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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) |
All cause mortality after 6 months
All cause mortality after 24 months
Rate of recurrent VT after 24 months
Rate of major or clinically relevant non-major bleeding after 24 months
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
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 | 12 |
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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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 |