Trials / Terminated
TerminatedNCT00344786
Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2008-07-01
- Completion
- 2008-09-01
- First posted
- 2006-06-27
- Last updated
- 2009-06-05
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00344786. Inclusion in this directory is not an endorsement.