Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

NCT ID: NCT00373373

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-07-31

Brief Summary

The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Chemotherapy + Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Chemotherapy + Placebo

B

Chemotherapy + Sorafenib

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

2 x 400 mg/d

Interventions

Sorafenib

2 x 400 mg/d

Intervention Type: DRUG

Placebo

Chemotherapy + Placebo

Intervention Type: DRUG

Other Intervention Names

Nexavar

Eligibility Criteria

Inclusion Criteria

• Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
• Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
• Age >= 61 years
• Informed consent, personally signed and dated to participate in the study
• Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib

Exclusion Criteria

• Central nervous system manifestation of AML
• Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Chronically impaired renal function (creatinin clearance < 30 ml/min)
• Chronic pulmonary disease with relevant hypoxia
• Inadequate liver function (ALT and AST >= 2.5 x ULN)
• Total bilirubin >= 1.5 x ULN
• Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
• Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
• Uncontrolled active infection
• Concurrent malignancies other than AML
• Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m²/d cytarabine
• Known HIV and/or hepatitis C infection
• Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
• Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
• Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
• History of organ allograft
• Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
• Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
• Serious, non-healing wound, ulcer or bone fracture
• Allergy to study medication or excipients in study medication
• Investigational drug therapy outside of this trial during or within 4 weeks of study entry
• Patients who are not eligible for standard chemotherapy

• Minimum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II

Principal Investigators

Hubert Serve, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II

Locations

Charité Campus Benjamin Franklin, Med. Klinik III

Berlin, , Germany

Klinikum Chemnitz GmbH, Klinik für Innere Medizin III

Chemnitz, , Germany

Klinikum der Universität zu Köln, Klinik I für Innere Medizin

Cologne, , Germany

Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik I

Dresden, , Germany

St. Johannes Hospital, Medizinische Klinik II

Duisburg, , Germany

Universitätsklinikum Essen, Zentrum für Innere Medizin, Medizinische Klinik und Poliklinik für Hämatologie

Essen, , Germany

Klinikum der J. W. Goethe-Universität Frankfurt am Main, Medizinische Klinik II

Frankfurt am Main, , Germany

Allgemeines Krankenhaus St. Georg, Hämatologische Abteilung

Hamburg, , Germany

Universitätsklinikum Heidelberg, Med. Klinik V

Heidelberg, , Germany

Klinikum der Johannes Gutenberg Universität, 3. Medizinische Klinik und Poliklinik

Mainz, , Germany

Philipps Universität, Abteilung für Hämatologie, Onkologie und Immunologie

Marburg, , Germany

Klinik für Hämatologie und Onkologie Klinikum Minden

Minden, , Germany

TU München, Medizinische Klinik III

München, , Germany

Universitätsklinikum Münster, Medizinische Klinik A

Münster, , Germany

Klinikum Nürnberg, 5. Medizinische Klinik Einheit für Knochenmarktransplantation

Nuremberg, , Germany

Universität Regensburg, Abteilung für Hämatologie und Internistische Onkologie

Regensburg, , Germany

Robert-Bosch Krankenhaus Stuttgart

Stuttgart, , Germany

Julius-Maximilians-Universität Würzburg, Medizinische Klinik und Poliklinik II

Würzburg, , Germany

Countries

Germany

Other Identifiers

EudraCT Number: 2005-005966-35

Identifier Type: -

Identifier Source: secondary_id

Sorafenib in AML

Identifier Type: -

Identifier Source: secondary_id

KKS/INNERE_A/AML2006

Identifier Type: -

Identifier Source: org_study_id