drugset / Trial / NCT05519917

Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

NCT05519917

Phase 2 Unknown 20 enrolled Huashan Hospital Boehringer Ingelheim · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, open label, single center, and prospective, interventional study to explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull base by objective response rate (ORR). The Secondary objectives is to assess progression free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage degree in patients with chordoma of skull base after using afatinib; to evaluate the safety and tolerability of afatinib in patients with chordoma of skull base.

Timeline

Start
2022-10-01
Primary completion
2025-06-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral

Indications