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

B-Cell Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00344786
• Other study ID #: CNF2024-CLL-05002
• Secondary ID: 120CL101
• Status: Terminated
• Phase: Phase 1
• First received: June 23, 2006
• Last updated: June 4, 2009
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

CLL dosing escalating study; daily dosing schedule; PK/PD safety

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 information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Research site	Houston	Texas
United States	Research site	New York	New York
United States	Research Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toxicity (maximum tolerated dose (MTD))		4 week periods until MTD is reached	Yes
Primary	Pharmacokinetics		Dosing period	No
Primary	Pharmacodynamics		Dosing period	No
Secondary	To determine clinical and hematological response		Study Duration	No
Secondary	To determine the recommended Phase 2 dose		Study duration	No