Status:
TERMINATED
Study of IMC-EB10 in Participant With Leukemia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if IMC-EB10 is safe for participants with leukemia, and also to determine the best dose of IMC-EB10 to give to participants.
Detailed Description
The purpose of this study is to define the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of the anti-FMS-like tyrosine kinase 3 (FLT3) monoclonal antibody IMC-EB10, administered we...
Eligibility Criteria
Inclusion
- The participant has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission
- The participant is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia
- The participant has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria
- The participant has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of IMC-EB10
- The participant has an Eastern Cooperative Oncology Group (ECOG)performance status of 0, 1, or 2 at study entry.
- The participant is age 18 years or older
- The participant has a life expectancy of \>3 months
- The participant has adequate liver and kidney function, as defined in the entry criteria
- The participant is using an effective contraception (per the institutional standard), if procreative potential exists
- The participant is able to give written informed consent
- The participant is willing and able to comply with study procedures, scheduled visits, and treatment plans
Exclusion
- The participant has had prior allogenic or autologous stem cell transplant within \<3 months of the first infusion of IMC-EB10
- The participant has had an organ transplant (nonhematologic) within 3 years of study entry
- The participant has active central nervous system leukemia
- The participant has extramedullary disease without peripheral/and or bone marrow involvement
- The participant is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. A participant who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study
- The participant is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted
- The participant has uncontrolled intercurrent illness as specified in the study entry criteria
- The participant is receiving chronic steroid or other immunosuppressive medications. Occasional use of steroid-containing medications for, for example (e.g.), asthma exacerbation or for skin lesions, is permitted
- The participant is receiving full-dose heparin (including low molecular weight heparin) or warfarin. \[The participant is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling intravenous (I.V.) catheters.\]
- The participant is pregnant (confirmed by urine or serum pregnancy test) or breast feeding
- The participant has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10
- The participant has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00887926
Start Date
June 1 2009
End Date
August 1 2010
Last Update
December 22 2022
Active Locations (2)
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1
ImClone Investigational Site
Columbus, Ohio, United States, 43210
2
ImClone Investigational Site
Houston, Texas, United States, 77030