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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344786
Recruitment Status : Terminated (Sponsor's decision)
First Posted : June 27, 2006
Last Update Posted : June 5, 2009
Information provided by:

Brief Summary:
CLL dosing escalating study; daily dosing schedule; PK/PD safety

Condition or disease Intervention/treatment Phase
B-Cell Chronic Lymphocytic Leukemia Drug: CNF2024 (BIIB021) Phase 1

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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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 Name: Single arm trial; no comparator

Primary Outcome Measures :
  1. Safety and toxicity (maximum tolerated dose (MTD)) [ Time Frame: 4 week periods until MTD is reached ]
  2. Pharmacokinetics [ Time Frame: Dosing period ]
  3. Pharmacodynamics [ Time Frame: Dosing period ]

Secondary Outcome Measures :
  1. To determine clinical and hematological response [ Time Frame: Study Duration ]
  2. To determine the recommended Phase 2 dose [ Time Frame: Study duration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00344786

United States, California
Research Site
San Diego, California, United States, 92093
United States, New York
Research site
New York, New York, United States, 10021
United States, Texas
Research site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Study Chair: Chris Storgard, MD Biogen

Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00344786     History of Changes
Other Study ID Numbers: CNF2024-CLL-05002
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009

Keywords provided by Biogen:
Hsp90 inhibitor

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell