drugset / Trial / NCT02020577

Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours

NCT02020577

Phase 1 Completed 58 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced solid tumours (except sarcomas).

Timeline

Start
2013-12
Primary completion
2015-01
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 30 mg
Subject Afatinib Small molecule 40 mg
Subject Cetuximab Monoclonal antibody 250 mg/m2

Indications