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

Biogen

Status and phase

Terminated

Phase 1

Conditions

B-Cell Chronic Lymphocytic Leukemia

Treatments

Drug: CNF2024 (BIIB021)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00344786

120CL101

CNF2024-CLL-05002

Details and patient eligibility

About

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

Full description

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

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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