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

NCT00344786 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2009-06-05

No results posted yet for this study

Summary

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

Conditions

  • B-Cell Chronic Lymphocytic Leukemia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Chris Storgard, MD · Biogen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-07-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344786 on ClinicalTrials.gov