drugset / Trial / NCT02372006

Trial of Afatinib in Pediatric Tumours

NCT02372006

Phase 1/2 Completed 56 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

Timeline

Start
2015-04-29
Primary completion
2020-08-05
Completion
2020-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 18 mg/m2 Oral
Subject Afatinib Small molecule 23 mg/m2 Oral