A Multicenter, Open Label Phase I / II Study of CEP-701 (Lestaurtinib) in Adults with Myelofibrosis
Investigator:
Maria Baer, M.D.
Summary:
The purpose of this study is to find the safest dose of the experimental drug lestaurtinib (also known as CEP-701), and to see if it is effective for treating myelofibrosis. Experimental means that the study drug is being tested in people but has not been approved by the FDA. The FDA has allowed this drug to be tested in this study. The protein JAK2 is found in the majority of myelofibrosis patients. CEP-701 is being studied to see if it will stop this protein from functioning and thereby help control the disease. There will be 5 different dose levels planned for the study (80 mg, 100 mg, 120 mg, 140 mg, and 160 mg). Each dose will be given by mouth twice a day.
Disease site:
Hematologic Malignancies
Disease stage:
N/A
Condition:
primary myelofibrosis, essential thrombocythemia related myelofibrosis, or polycythemia
Intervention:
Experimental
Phase:
I/II
Study number:
GCC 0856
Eligibility*
(inclusion criteria)
1.Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis, or polycythemia vera related myelofibrosis requiring therapy.
2. NOT a candidate to receive allogeneic hematopoietic stem cell transplant.
3. detectable JAK2 V617F mutation.
4. consents for both the Lestaurtinib protocol & mandatory biomarker MDP-RC study.
5. Must be off any PMF-directed therapy for 4 weeks prior to entering this study and reover to grade 0-1toxicity of that therapy. Treatment with erythropoietin and hydroxyurea are permitted.
6. Bilirubin levels less than or equal to 2 times the upper limit of the normal.
7. SGPT / ALT levels less than or equal to 2 x ULN.
8. ECOG performance status of 0, 1, or 2.
9. Negative serum or urine pregnancy test for WOCBP.
10. Age 18 years or older.
(exclusion criteria)
1. Nursing and pregnant females.
2. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
3. Unstable angina.
4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days, or anticipation of the need for major surgical procedure during the course of the study.
5. Biopsy or other minor surgical procedure, excluding placement of a vascular access device or bone marrow biopsy, within 7 days prior to study enrollment.
6. Ongoing serious, non-healing wound, ulcer, or bone fracture.
7. Known hypersensitivity to any component of Lestaurtinib.
8. Donor stem cell transplant recipient and detectable full or partial donor
chimerism.
9. The subject requires treatment with a CYP3A4 inhibitor.
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.
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