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

Phase 1
18 Years
Not Enrolling
B-Cell Chronic Lymphocytic Leukemia

Thank you

Trial Information

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

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

Inclusion Criteria:

- Patients with CLL who relapsed following or are intolerant to purine analog -based

- 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

- Patients with secondary malignancy requiring active treatment (except hormonal

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Safety and toxicity (maximum tolerated dose (MTD))

Outcome Time Frame:

4 week periods until MTD is reached

Safety Issue:


Principal Investigator

Chris Storgard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Biogen Idec


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

September 2008

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • CLL
  • CNF2024
  • Hsp90 inhibitor
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Research Site Anaheim, California  
Research Site Albany, New York  
Research Site Abilene, Texas