Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Sponsor's decision)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00344786
First received: June 23, 2006
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety and toxicity (maximum tolerated dose (MTD)) [ Time Frame: 4 week periods until MTD is reached ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Dosing period ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: Dosing period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine clinical and hematological response [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
  • To determine the recommended Phase 2 dose [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344786

Locations
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
Biogen Idec
Investigators
Study Chair: Chris Storgard, MD Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00344786     History of Changes
Other Study ID Numbers: CNF2024-CLL-05002, 120CL101
Study First Received: June 23, 2006
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
CLL
CNF2024
Hsp90 inhibitor

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

ClinicalTrials.gov processed this record on November 25, 2014