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

NCT ID: NCT00344786

Last Updated: 2009-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-09-30

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

Conditions

B-Cell Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CNF2024

Group Type: EXPERIMENTAL

CNF2024 (BIIB021)

Intervention Type: DRUG

Dose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period.

Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment.

Interventions

CNF2024 (BIIB021)

Dose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period.

Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment.

Intervention Type: DRUG

Other Intervention Names

Single arm trial; no comparator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec

Principal Investigators

Chris Storgard, MD

Role: STUDY_CHAIR

Biogen

Locations

Research Site

San Diego, California, United States

Research site

New York, New York, United States

Research site

Houston, Texas, United States

Countries

United States

Other Identifiers

120CL101

Identifier Type: -

Identifier Source: secondary_id

CNF2024-CLL-05002

Identifier Type: -

Identifier Source: org_study_id