Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00783653
First received: October 31, 2008
Last updated: September 20, 2013
Last verified: September 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 [ Time Frame: April 2011 ] [ 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 [ Time Frame: April 2011 ] [ 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 [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2008
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sunitinib
    25 mg or 37,5 mg daily dose until DLT
    Other Name: SU11248, Sutent
  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
Hamburg, Germany, 20246
PD Dr. med. Jürgen Krauter
Hannover, Germany, 30625
Dr. Katharina Götze
München, Germany, 81675
Prof. Dr. Helmut R. Salih
Tübingen, Germany, 72076
Dr. Richard Schlenk
Ulm, Germany, 89081
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Walter Fiedler Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00783653     History of Changes
Other Study ID Numbers: AMLSG 10/07, AMLSG-SU11248
Study First Received: October 31, 2008
Last Updated: September 20, 2013
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

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

ClinicalTrials.gov processed this record on April 17, 2014