NCT05519917

Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

An Open-label, Single-arm, Interventional Clinical Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chordoma of Clivus

Interventions

Type	Name	Description
DRUG	Afatinib	Subjects will receive evaluations at the beginning of treatment, after every three cycles and at the end of the whole study.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2022-08-29
• Last updated: 2022-09-30

Locations

1 site across 1 country: China