Trials / Completed
CompletedNCT00309179
A Phase II Study of the Safety and Efficacy of E7820 Plus Cetuximab in Colorectal Cancer, Preceded by a Run-in Study in Advanced Solid Tumors
A Single Arm Phase II Study of the Efficacy, Safety, and Biomarkers of Activity of E7820 Plus Cetuximab in Advanced Solid Tumors Preceded by a Run-In Study to Determine Safety of the Combination
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study proposes to determine the safety of the administration of E7820 plus cetuximab and explore the MTD of the combination in a Phase Ib study. In addition, the efficacy of this combination will be explored in patients with colorectal cancer in the Phase II proof of concept phase of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7820 plus cetuximab | Escalating doses from 40 mg/m\^2 irinotecan plus E7820 in combination with cetuximab. |
Timeline
- Start date
- 2007-09-24
- Primary completion
- 2009-12-14
- Completion
- 2017-02-13
- First posted
- 2006-03-31
- Last updated
- 2017-09-14
Locations
3 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00309179. Inclusion in this directory is not an endorsement.