Afatinib in Locally Advanced and Metastatic Chordoma
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
In this phase 2, single arm trial patients with locally advanced or metastatic,
pathologically proven, EGFR expressing chordoma will be treated with afatinib. Two cohorts of
patients will be included: 20 first line patients and 20 second or further line patients. The
treatment will be given in 4 week cycles until disease progression. Median PFS according to
RECIST 1.1 will be evaluated. The objective is to increase the median PFS ≥ 12 months in
first-line treatment cohort and ≥ 9 months in later-line treatment cohort. Additional
exploratory research will be performed, consisting of a pharmacokinetic study and
translational studies on EGFR pathway activation and signalling on blood and tumor samples.