Status:
UNKNOWN
An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation
Lead Sponsor:
AZ-VUB
Conditions:
Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objective(s):To investigate the efficacy and safety of afatinib in EGFR, HER 2 and HER3 mutated cancers, regardless of cancer type, excluding EGFR mutated non-small cell lung cancer. Methodology:Open...
Eligibility Criteria
Inclusion
- Women and men with locally advanced or metastatic cancers harboring either an activating EGFR mutation or a HER2 mutation or a HER3 mutation
- Failure of at least one line of standard systemic therapy
- No eligibility for other open genomic driven phase I, II or III trial available for these tumor genotypes
- ECOG performance status ≤2
- Patient with a life expectancy \>3 months
- Patients able to provide written informed consent prior to enrollment into the clinical trial.
- Adequate organ function
Exclusion
- Non squamous non-small cell lung cancer harbouring an EGFR mutation (registered indication)
- Chemotherapy, biological therapy or investigational agents within four weeks prior to the start of study treatment
- Known hypersensitivity to afatinib or the excipients of any of the trial drugs
- Prior treatment with afatinib
Key Trial Info
Start Date :
June 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03810872
Start Date
June 21 2017
End Date
December 1 2022
Last Update
January 22 2019
Active Locations (5)
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1
Institut Jules Bordet
Brussels, Belgium, 1000
2
Les Cliniques Universitaires St Luc
Brussels, Belgium, 1200
3
Universitaire Ziekenhuis Antwerpen
Edegem, Belgium, 2650
4
UZ Gent
Ghent, Belgium, 9000