Status:
TERMINATED
Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
Lead Sponsor:
Biogen
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00344786
Start Date
February 1 2006
End Date
September 1 2008
Last Update
June 5 2009
Active Locations (3)
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1
Research Site
San Diego, California, United States, 92093
2
Research site
New York, New York, United States, 10021
3
Research site
Houston, Texas, United States, 77030