The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
5-20 mg/kg; intravenous; Days 0, 14, 28, and 42. Number of cycles: until progression or unacceptable toxicity develops.
2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.
University of California, San Francisco
San Francisco, California, United States
Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC
Time frame: Up to 2 years
Maximum Tolerated Dose (MTD) for ficlatuzumab when administered with HiDAC
Time frame: Up to 2 years
Preliminary activity of ficlatuzumab in combination with HiDAC in patients with relapsed or refractory AML
Time frame: Up to 2 years
Functional status for patients receiving ficlatuzumab and HiDAC
Time frame: Up to 2 years
Quality of life for patients receiving ficlatuzumab and HiDAC
Time frame: Up to 2 years
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