Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
Phase 1
Terminated
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- Drug: CNF2024 (BIIB021)
- Registration Number
- NCT00344786
- Lead Sponsor
- Biogen
- Brief Summary
CLL dosing escalating study; daily dosing schedule; PK/PD safety
- Detailed 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CNF2024 CNF2024 (BIIB021) -
- Primary Outcome Measures
Name Time Method Safety and toxicity (maximum tolerated dose (MTD)) 4 week periods until MTD is reached Pharmacokinetics Dosing period Pharmacodynamics Dosing period
- Secondary Outcome Measures
Name Time Method To determine clinical and hematological response Study Duration To determine the recommended Phase 2 dose Study duration
Trial Locations
- Locations (2)
Research Site
🇺🇸San Diego, California, United States
Research site
🇺🇸Houston, Texas, United States