Afatinib in Locally Advanced and Metastatic Chordoma

NCT03083678 PHASE2 COMPLETED

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.

Details

Lead sponsor	Leiden University Medical Center
Phase	PHASE2
Status	COMPLETED
Enrolment	43
Start date	Thu Jun 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Chordoma

Interventions

• Afatinib

Countries

Italy, Netherlands, United Kingdom