Spots Global Cancer Trial Database for Afatinib in Locally Advanced and Metastatic Chordoma
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Trial Identification
Brief Title: Afatinib in Locally Advanced and Metastatic Chordoma
Official Title: A Phase 2, Single Arm, European Multi-center Trial Evaluating the Efficacy of Afatinib as First-line or Later-line Treatment in Advanced Chordoma.
Study ID: NCT03083678
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto Nazionale dei Tumori: Fondazione IRCCS, Milan, , Italy
Leiden University Medical Center, Leiden, , Netherlands
University College London Hospital, London, , United Kingdom
Contact Details
Name: AJ Gelderblom, Prof
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
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