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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Page 1 of 2 (5 locations)

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