Know Cancer

or
forgot password

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


Phase 2
61 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Median Event Free Survival of all AML patients

Principal Investigator

Hubert Serve, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

KKS/INNERE_A/AML2006

NCT ID:

NCT00373373

Start Date:

September 2006

Completion Date:

July 2009

Related Keywords:

  • Acute Myeloid Leukemia
  • Sorafenib
  • Acute Myeloid Leukemia
  • Flt3
  • AML
  • Kinase Inhibitor
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location