E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients older than 60 years with newly diagnosed acute myeloid leukemia (AML) |
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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 compare the median event free survival (EFS) of AML patients between the Sorafenib and the control group |
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E.2.2 | Secondary objectives of the trial |
-to compare the EFS of AML patients with Flt3 mutations between the Sorafenib and the control group
-to compare EFS of AML patients in each of the four strata
-to compare OS of AML patients between the Sorafenib and the control group
-to compare the CR-rate of AML patients between the Sorafenib and the control group
-to compare the molecular remissions of AML patients between the Sorafenib and the control group
-to compare the toxicity between the Sorafenib and the control group
-to compare the evidence of minimal residual disease of all AML patients between the Sorafenib and the control group after induction therapy and in the course of the first remission
-to compare the development of biomarkers indicating the course of disease in leukemic blasts, bone marrow, peripheral blood cells, serum and plasma
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 60 years with newly diagnosed AML (except APL) according to FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) |
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E.4 | Principal exclusion criteria |
-Central nervous system manifestations of AML
-Uncontrolled active infection
-Concurrent malignancies other than AML
-Previous treatment of AML exept hydroxyurea and up to 2 days < or = 100 mg/m² cytarabine
-Patients who are not eligible for standard chemotherapy as described in chapter 6.2 and 6.3 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Event free Survival(EFS): measured from patient's day 1 of the study until treatment failure, relapse from CR or Morphologic leukemia-free state, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR or Morphologic leukemia-free state will be noted. For a patient with none of these events before the end of the study follow-up, observation of EFS will be censored at the date of his or her last follow-up examination. |
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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 | 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 | 18 |
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 | 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
|
The study will end one month after end of therapy of last patient. |
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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 | 25 |
E.8.9.1 | In the Member State concerned days | |