Trials / Completed
CompletedNCT00866944
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Amgen Research (Munich) GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adecatumumab | Adecatumumab,6-9mg/kg, every 14 days, 24 cycles |
| DRUG | Adecatumumab and FOLFOX | FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles |
| DRUG | FOLFOX 4 | FOLFOX 4, every 14 days, 12 cycles |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2011-07-01
- Completion
- 2011-11-01
- First posted
- 2009-03-23
- Last updated
- 2011-11-11
Locations
16 sites across 2 countries: France, Germany
Source: ClinicalTrials.gov record NCT00866944. Inclusion in this directory is not an endorsement.