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

Tracking Information

First Received Date ^ICMJE

September 6, 2006

Last Updated Date

August 18, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Median Event Free Survival of all AML patients

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00373373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Drug: Sorafenib
Drug: Placebo

Study Arms / Comparison Groups

Placebo Comparator: Chemotherapy + Placebo
Active Comparator: Chemotherapy + Sorafenib

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

61 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00373373

Responsible Party

Hubert Serve (Principal Investigator), Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II

Study ID Numbers ^ICMJE

KKS/INNERE_A/AML2006, EudraCT Number: 2005-005966-35, Sorafenib in AML

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

Principal Investigator:

Hubert Serve, MD

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

Information Provided By

University Hospital Muenster

Verification Date

August 2009

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