NCT00344786

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

2.4 years

First QC Date

June 23, 2006

Last Update Submit

June 4, 2009

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

CLLCNF2024Hsp90 inhibitor

Outcome Measures

Primary Outcomes (3)

  • Safety and toxicity (maximum tolerated dose (MTD))

    4 week periods until MTD is reached

  • Pharmacokinetics

    Dosing period

  • Pharmacodynamics

    Dosing period

Secondary Outcomes (2)

  • To determine clinical and hematological response

    Study Duration

  • To determine the recommended Phase 2 dose

    Study duration

Study Arms (1)

CNF2024

EXPERIMENTAL
Drug: CNF2024 (BIIB021)

Interventions

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.

Also known as: Single arm trial; no comparator
CNF2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

San Diego, California, 92093, United States

Location

Research site

New York, New York, 10021, United States

Location

Research site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chris Storgard, MD

    Biogen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

US(3)