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Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years
This study is currently recruiting participants.
Verified by Universitätsklinikum Hamburg-Eppendorf, October 2008
Sponsors and Collaborators: Universitätsklinikum Hamburg-Eppendorf
Pfizer
CenTrial GmbH, Tübingen
Information provided by: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00783653
  Purpose

In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Sunitinib
Phase I
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Cytarabine Cytarabine hydrochloride Daunorubicin hydrochloride Daunorubicin Sunitinib Sunitinib malate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
Official Title: Phase I/II Clinical Study of SU11248 (Sutent) Combined With Standard Chemotherapy With Cytosine Arabinoside and Daunorubicin in Patients With FLT3 Mutated AML Over 60 Years of Age

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Definition of a recommended Phase III dose and determination CTC version 3.0 grade 3-5 non-hematological toxicities of SU11248 in combination with standard induction and consolidation chemotherapy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall safety profile of SU11248 characterized by type, frequency, severity (graded using NCI CTCAE Version 3.0), timing and relatedness of adverse events (AEs) and laboratory [ Designated as safety issue: Yes ]
  • Objective tumor response, as defined using the revised recommendations of the International Working Group for diagnosis, standardization of response criteria in Acute Myeloid Leukemia for AML [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: August 2008
Intervention Details:
    Drug: Sunitinib
    25 mg or 37,5 mg daily dose until DLT
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary or secondary acute myeloid leukemia (any FAB type, except M3).
  • No prior systemic chemotherapy for AML except hydroxyurea. Cytoreductive therapy with hydroxyurea is recommended if WBC is > 50.000/µl, but should cease at least one day prior to starting study medication
  • Patient age equal or of greater than 60 years
  • Patients must have FLT3 mutated AML, either ITD or kinase domain mutations
  • ECOG Performance score 3 or less (Karnofsky Performance Score >40%).
  • Life expectancy more than four weeks.
  • Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN, bilirubin <1.5x ULN. Creatinine <1.5x ULN.
  • Patients must provide written informed consent to participate in the trial.
  • Normal heart function on cardiac ultrasound
  • Prothrombin time (PT) and partial thromboplastin time (PTT) <=1.5 x ULN
  • Serum albumin >=3.0 g/dl
  • Serum amylase and lipase <=1.0 x ULN
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

  • Treatment with any investigational agent within four weeks.
  • Known HIV infection
  • Presence of any medical or psychiatric condition which may limit full compliance with the study, including but not limited to:
  • Presence of CNS leukaemia
  • Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery.
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
  • Current treatment with therapeutic doses of anticoagulant (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Pre existing thyroid abnormality of thyroid function that cannot be maintained in the normal range with medication.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of any Grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783653

Locations
Germany
Prof. Dr. med. Walter Fiedler Recruiting
Hamburg, Germany, 20246
Contact: Walter Fiedler     040 42803 3919     fiedler@uke.uni-hamburg.de    
Sub-Investigator: Friederike Lehmann            
Sub-Investigator: Carola Reimer            
PD Dr. med. Jürgen Krauter Recruiting
Hannover, Germany, 30625
Contact: Jürgen Krauter     49 0511 532-3720     Krauter.Juergen@MH-Hannover.DE    
Sub-Investigator: Arnold Ganser            
Sub-Investigator: Martin Fenner            
Sub-Investigator: Matthias Port            
Sub-Investigator: Frederik Damm            
Richard Schlenk Not yet recruiting
Ulm, Germany, 89081
Contact: Richard Schlenk     49 731 50045900     Richard.Schlenk@uniklinik-ulm.de    
Sub-Investigator: Marie Hütter            
Sub-Investigator: Jochen Greiner            
Sub-Investigator: Hartmut Döhner            
Sub-Investigator: Konstanze Döhner            
Sub-Investigator: Martin Bommer            
Sub-Investigator: Mathias Schmid            
Katharina Götze Not yet recruiting
München, Germany, 81675
Contact: Katharina Götze     49 089 4140 5618     k.goetze@lrz.tum.de    
Sub-Investigator: Dr. med. Catharina Müller-Thomas            
Sub-Investigator: Justus Duyster            
Sub-Investigator: Dickhut            
Sub-Investigator: Barajweski            
Helmut R. Salih Not yet recruiting
Tübingen, Germany, 72076
Contact: Helmut Salih     49 07071 29 83275     helmut.salih@med.uni-tuebingen.de    
Sub-Investigator: Michael Böckeler            
Sub-Investigator: Valdete Mirakaj            
Sub-Investigator: Schittenhelm            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Pfizer
CenTrial GmbH, Tübingen
Investigators
Principal Investigator: Walter Fiedler Universitätsklinikum Hamburg-Eppendorf
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf ( Prof. Dr. Walter Fiedler )
Study ID Numbers: AMLSG 10/07, AMLSG-SU11248
Study First Received: October 31, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00783653  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
AML
FLT3
acute myeloid leukemia
FLT 3 inhibitor
FLT3 mutated AML

Study placed in the following topic categories:
Daunorubicin
Leukemia
Sunitinib
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009