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

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-06-23
• Study First Submitted QC: 2006-06-23
• Study First Posted: 2006-06-27
• Primary Completion: 2008-07
• Study Completion: 2008-09
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-04
• Last Update Posted: 2009-06-05

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