Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL

A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)

CLL dosing escalating study; daily dosing schedule; PK/PD safety

Phase 1, open-label, accelerated-titration study designed to evaluate the effects of increasing doses of CNF2024 on safety, pharmacokinetics, pharmacodynamic markers, and hematological response

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