NCT03083678

Afatinib in Locally Advanced and Metastatic Chordoma

A Phase 2, Single Arm, European Multi-center Trial Evaluating the Efficacy of Afatinib As First-line or Later-line Treatment in Advanced Chordoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chordoma

Interventions

Type	Name	Description
DRUG	Afatinib	Afatinib will be given daily in a dose of 40 mg orally in a 4 week cycle until disease progression or patient withdrawal.

Timeline

• Start date: 2018-06-21
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2017-03-20
• Last updated: 2025-02-13

Locations

3 sites across 3 countries: Italy, Netherlands, United Kingdom