drugset / Trial / NCT00925769

ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer

NCT00925769 ↗

Phase 1 Completed 32 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This 2 part study will evaluate the safety and efficacy of a combination of Avastin, Tarceva and Xeloda (ATX) as second-line treatment in patients with locally advanced and/or metastatic pancreatic cancer. In the first part of the study, cohorts of patients will receive escalating doses of combination treatment to determine the maximum tolerated dose. The recommended dose will be used in the second part of the study to determine the efficacy of the ATX regime, in terms of its effect on disease progression. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Timeline

Start
2009-01
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg —
Subject Bevacizumab Monoclonal antibody 10 mg/kg —
Subject Capecitabine Small molecule 500 mg/m2 —
Subject Capecitabine Small molecule 650 mg/m2 —
Subject Capecitabine Small molecule 750 mg/m2 —
Subject Capecitabine Small molecule 900 mg/m2 —
Subject Erlotinib Small molecule 100 mg —
Subject Erlotinib Small molecule 150 mg —