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

Universitätsklinikum Hamburg-Eppendorf5 sites in 1 country22 target enrollmentAugust 2008

ConditionsAcute Myeloid Leukemia

DrugsSunitinib

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 22
Locations: 5
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

July 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Sponsor

Eligibility 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

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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(April 2011)
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(April 2011)