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

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

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

Study Overview

• Status: Terminated
• Conditions: B-Cell Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: CNF2024 (BIIB021)

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Research Site
  • New York
    • New York, New York, United States, 10021
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CNF2024	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.; Other Names: Single arm trial; no comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and toxicity (maximum tolerated dose (MTD))	4 week periods until MTD is reached
Pharmacokinetics	Dosing period
Pharmacodynamics	Dosing period

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine clinical and hematological response	Study Duration
To determine the recommended Phase 2 dose	Study duration

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Chair: Chris Storgard, MD, Biogen

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 23, 2006
• First Submitted That Met QC Criteria: June 23, 2006
• First Posted (Estimate): June 27, 2006

Study Record Updates

• Last Update Posted (Estimate): June 5, 2009
• Last Update Submitted That Met QC Criteria: June 4, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: CLL; Hsp90 inhibitor; CNF2024
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: CNF2024-CLL-05002; 120CL101