Trials / Completed
CompletedNCT00875264
Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
An Open-Label Study to Determine the Maximum Tolerated Oral Dose of the Kinase Inhibitor CEP-11981 in Patients With Advanced Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Cephalon · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities of CEP-11981 in patients with advanced, relapsed/refractory solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CEP-11981 (kinase inhibitor) | Patients will be treated with oral CEP-11981 once daily for 28 days, followed by a treatment-free period of 14 days. This 42-day (6-week) period will constitute 1 cycle. The starting dose for the study will be 3 mg/m2. Dose escalation from this starting dose follows a modified Fibonacci sequence. |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2009-04-03
- Last updated
- 2012-07-25
Source: ClinicalTrials.gov record NCT00875264. Inclusion in this directory is not an endorsement.