NCT01579357

Pharmacokinetics and Metabolic Activation of Capecitabine

Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	blood samples	Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-04-18
• Last updated: 2015-03-09

Locations

3 sites across 1 country: Austria