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Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors

NCT00345189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2009-07-14

No results posted yet for this study

Summary

This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.

Conditions

Interventions

DRUG

CNF2024

CNF2024 capsules administered orally following 2 schedules: * starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or * starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.

Sponsors & Collaborators

Principal Investigators

  • Biogen Idec Medical Monitor, MD · Biogen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-07-31
Completion
2009-04-30

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT00345189 on ClinicalTrials.gov