Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00373373
First received: September 6, 2006
Last updated: August 18, 2009
Last verified: August 2009

September 6, 2006
August 18, 2009
September 2006
July 2009   (final data collection date for primary outcome measure)
Median Event Free Survival of all AML patients
Same as current
Complete list of historical versions of study NCT00373373 on ClinicalTrials.gov Archive Site
  • Median Event Free Survival of AML patients with Flt3-ITD mutations
  • Median Event Free Survival of the patients in each of the four strata (Flt3 Non-ITD/NPM1 WT, Flt3 Non-ITD/NPM1 mut, Flt3 ITD/NPM1 WT, Flt3 ITD/NPM1 mut)
  • Median Overall Survival of AML patients with Flt3-ITD mutations
  • Median Overall Survival of all AML patients
  • Rate of Complete Remission in all AML patients
  • Rate of Molecular Remission in all AML patients
  • Toxicity
  • Evidence of Minimal Residual Disease in all AML patients
  • Development of Biomarkers indicating the course of disease
Same as current
Not Provided
Not Provided
 
Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
A Double-blind, Placebo-controlled, Randomized, Multi-center Phase II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Sorafenib
    2 x 400 mg/d
    Other Name: Nexavar
  • Drug: Placebo
    Chemotherapy + Placebo
  • Placebo Comparator: A
    Chemotherapy + Placebo
    Intervention: Drug: Placebo
  • Active Comparator: B
    Chemotherapy + Sorafenib
    Intervention: Drug: Sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
61 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00373373
KKS/INNERE_A/AML2006, EudraCT Number: 2005-005966-35, Sorafenib in AML
Yes
Hubert Serve (Principal Investigator), Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II
University Hospital Muenster
Bayer
Principal Investigator: Hubert Serve, MD Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II
University Hospital Muenster
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP