Trials / Completed
CompletedNCT01450319
Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favorable FcγRIIa (CD32) Genotype
Phase II Clinical Study of Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favourable FcγR IIa (CD32) Genotype
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This national, multicenter, open-label phase 2 study without any control arm aims to evaluate the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic alternative for treatment. Failure of the first and second line conventional therapeutic lines was documented.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cetuximab | Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m\^2) every 2 weeks until disease progression, death, or consent withdrawal. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2011-10-12
- Last updated
- 2016-11-28
- Results posted
- 2016-06-15
Locations
9 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01450319. Inclusion in this directory is not an endorsement.