NCT00344786
Terminated
Phase 1
A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Biogen
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Safety and toxicity (maximum tolerated dose (MTD))
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CNF2024
Experimental
Intervention: CNF2024 (BIIB021) (Drug)
Outcomes
Primary Outcomes
Safety and toxicity (maximum tolerated dose (MTD))
Time Frame: 4 week periods until MTD is reached
Pharmacokinetics
Time Frame: Dosing period
Pharmacodynamics
Time Frame: Dosing period
Secondary Outcomes
- To determine clinical and hematological response(Study Duration)
- To determine the recommended Phase 2 dose(Study duration)
Investigators
Study Sites (2)
Loading locations...
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