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Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT05519917•Huashan Hospital

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients of 18 years and above;
•Patients with pathologically proven EGFR and/or HER2 expressing relapsed or residual chordoma of skull base, inappropriate or unwilling to receive surgery or radiotherapy;
•Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 75 x 109/L);
•An adequate renal function with GFR ≥ 45 ml/min calculated by Cockroft-Gault formula;
•Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ 3 times ULN;
•Ability to swallow medication;
•Able to understand and provide written informed consent prior to any study procedures.

Exclusion Criteria

•Life expectancy of less than 3 months;
•Known hypersensitivity to afatinib;
•Major surgery less than 4 weeks prior to start of the study;
•Patients who once participated in other clinical trials within 14 days before the initiation of the study;
•Systemic anti-cancer therapy within 28 days prior to start of the study;
•No tumor progression after radiation therapy prior to start of the study;
•History or presence of serious cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia, and myocardial infarction within 6 months prior to inclusion;
•Known pre-existing interstitial lung disease;
•No response after 2-week active treatment for known CTCAE Grade 3 or Grade 2 rash/acne;
•Any history or presence of poorly controlled gastrointestinal disorders that may worsen after administration and could affect the absorption of the study drug (e.g. diarrhea, Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption);
+7 more criteria

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

June 30, 2025

Completion Date

December 30, 2025

Last Updated

September 30, 2022

Enrollment

ESTIMATED participants

Conditions

Chordoma of Clivus

Interventions

Afatinib

DRUG

Contacts

Qilin Zhang, MD

CONTACT

86-21-52889999 zhangqlhuashan@163.com