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

Primary Purpose

B-Cell Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CNF2024 (BIIB021)
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Chronic Lymphocytic Leukemia focused on measuring CLL, CNF2024, Hsp90 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CNF2024

Arm Description

Outcomes

Primary Outcome Measures

Safety and toxicity (maximum tolerated dose (MTD))
Pharmacokinetics
Pharmacodynamics

Secondary Outcome Measures

To determine clinical and hematological response
To determine the recommended Phase 2 dose

Full Information

First Posted
June 23, 2006
Last Updated
June 4, 2009
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00344786
Brief Title
Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
Official Title
A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Chronic Lymphocytic Leukemia
Keywords
CLL, CNF2024, Hsp90 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CNF2024
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CNF2024 (BIIB021)
Other Intervention Name(s)
Single arm trial; no comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and toxicity (maximum tolerated dose (MTD))
Time Frame
4 week periods until MTD is reached
Title
Pharmacokinetics
Time Frame
Dosing period
Title
Pharmacodynamics
Time Frame
Dosing period
Secondary Outcome Measure Information:
Title
To determine clinical and hematological response
Time Frame
Study Duration
Title
To determine the recommended Phase 2 dose
Time Frame
Study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Storgard, MD
Organizational Affiliation
Biogen
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Research site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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