Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
B-Cell Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-Cell Chronic Lymphocytic Leukemia focused on measuring CLL, CNF2024, Hsp90 inhibitor
Eligibility Criteria
Inclusion Criteria: Patients with CLL who relapsed following or are intolerant to purine analog -based therapy Hemoglobin >=9 gm/dL (may be post-transfusion) Total bilirubin <2 X ULN, and ALT and AST <2 x ULN Creatinine <=2 X ULN Normal plasma cortisol and ACTH concentrations ECOG Performance Status <=2 Anticipated survival >=3 months For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after treatment Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments Exclusion Criteria: Pregnant or nursing women Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days before entering the study Participation in any investigational drug study within 28 days before CNF2024 administration Patients with secondary malignancy requiring active treatment (except hormonal therapy) Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis Problems with swallowing or malabsorption Diarrhea (excess of 2-3 stools/day above normal frequency in the past month) Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis Major surgery of the stomach or small intestine Adrenal dysfunction Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction) Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study's endpoints
Sites / Locations
- Research Site
- Research site
- Research site
Arms of the Study
Arm 1
Experimental
CNF2024