NCT00373373

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

September 6, 2006

Last Update Submit

August 18, 2009

Conditions

Acute Myeloid Leukemia

Keywords

SorafenibAcute Myeloid LeukemiaFlt3AMLKinase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Median Event Free Survival of all AML patients

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

A

PLACEBO COMPARATOR

Chemotherapy + Placebo

Drug: Placebo

B

ACTIVE COMPARATOR

Chemotherapy + Sorafenib

Drug: Sorafenib

Interventions

SorafenibDRUG

2 x 400 mg/d

Also known as: Nexavar
B
PlaceboDRUG

Chemotherapy + Placebo

A

Eligibility Criteria

Age61 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Charité Campus Benjamin Franklin, Med. Klinik III

Berlin, 12203, Germany

Location

Klinikum Chemnitz GmbH, Klinik für Innere Medizin III

Chemnitz, 09113, Germany

Location

Klinikum der Universität zu Köln, Klinik I für Innere Medizin

Cologne, 50937, Germany

Location

Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik I

Dresden, 01307, Germany

Location

St. Johannes Hospital, Medizinische Klinik II

Duisburg, 47166, Germany

Location

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

Essen, 45147, Germany

Location

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

Frankfurt am Main, 60590, Germany

Location

Allgemeines Krankenhaus St. Georg, Hämatologische Abteilung

Hamburg, 20099, Germany

Location

Universitätsklinikum Heidelberg, Med. Klinik V

Heidelberg, D-69120, Germany

Location

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

Mainz, 55101, Germany

Location

Philipps Universität, Abteilung für Hämatologie, Onkologie und Immunologie

Marburg, 35043, Germany

Location

Klinik für Hämatologie und Onkologie Klinikum Minden

Minden, 32423, Germany

Location

TU München, Medizinische Klinik III

München, 81675, Germany

Location

Universitätsklinikum Münster, Medizinische Klinik A

Münster, 48149, Germany

Location

Klinikum Nürnberg, 5. Medizinische Klinik Einheit für Knochenmarktransplantation

Nuremberg, 90419, Germany

Location

Universität Regensburg, Abteilung für Hämatologie und Internistische Onkologie

Regensburg, 93042, Germany

Location

Robert-Bosch Krankenhaus Stuttgart

Stuttgart, 70376, Germany

Location

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

Würzburg, 97979, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hubert Serve, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

DE(18)