cancers harbouring an EGFR mutation (excluding non-squamous non- small cell lung cancer, a registered indication), a HER2 mutation or a HER3 mutation
Conditions
Interventions
Trade Name: GIOTRF
Product Name: afatinib
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Afatinib
CAS Number: 850140-72-6
Current Sponsor code: BIBW 2992
Other de
Sponsors
BSMO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 87 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 87
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the objective response rate (CR+PR), using RECIST 1.1 criteria, of afatinib in cancers harbouring either an EGFR mutation, a HER2 mutation or a HER3 mutation, excluding EGFR mutated NSCLC and providing that there is no other tumour-specific genotype-based trial in Belgium for which the patient is eligible. ;Secondary Objective: - To evaluate disease control (CR+PR+SD) determined by RECIST - To evaluate Progression Free Survival (PFS) and overall survival (OS) - To evaluate safety by reporting all adverse events (AE) and grading using CTCAE criteria version 4.0 (33) - To correlate tumor response with findings on tumor biopsies, analyzed by immunohistochemistry (if relevant) and mutational analysis. - To investigate resistance mechanisms by performing a re-biopsy at progression - To evaluate response rate determined by RECIST 1.1 and PFS on the combination therapy of afatinib and paclitaxel ;Primary end point(s): The primary endpoint of this trial is objective response (CR+PR) according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Tumour assessment will be performed by CT or MRI of the chest and abdomen at baseline, every 8 weeks until cycle 7 and every 12 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Disease control rate (CR+PR+SD) according to RECIST 1.1 (34) - PFS defined as the time from treatment start until documented tumor progression or death of any cause, whichever occurs first - OS, defined as time from randomization until death (irrespective of reason). - Safety of afatinib as indicated by incidence and intensity of AEs graded according to CTCAE v4.0 (33) - To correlate tumor response with findings on tumor biopsies, analyzed by immunohistochemistry (if relevant) and mutational analysis - To investigate resistance mechanisms by performing a re-biopsy at progression - To evaluate response rate determined by RECIST 1.1 and PFS on the combination therapy of afatinib and paclitaxel ;Timepoint(s) of evaluation of this end point: Tumour assessment will be performed by CT or MRI of the chest and abdomen at baseline, every 8 weeks until cycle 7 and every 12 weeks thereafter | — |
Countries
Belgium
Contacts
Public ContactDr. Decoster
UZ Brussel
Outcome results
None listed