Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) i... | NCT00344786

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

NCT00344786

Sponsor

Biogen

Status

Terminated

Last Update Posted

Jun 5, 2009Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

CNF2024 (BIIB021)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
120CL101

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor's decision

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jun 23, 2006

First Submission Date that Met QC Criteria

Jun 23, 2006

First Posted Date

Jun 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2009

Last Update Posted Date

Jun 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CNF2024	Experimental		Drug: CNF2024 (BIIB021)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CNF2024 (BIIB021)	Drug	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.

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		San Diego	California	92093	United States
Research site

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type