Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
The purpose of this trial is to assess the anti-tumour activity and safety of afatinib
 monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3
 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family
 of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor
 Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum
 based chemotherapy, and thereby to improve their prognosis.

 The antitumour activity of afatinib monotherapy in these patients will be assessed by
 progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the
 trial. A key secondary endpoint will also be defined, the objective response rate (ORR).
Inclusion criteria:

 -  Recurrent or metastatic urothelial cancer

 -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)

 -  Archival tissue sample available for biomarker testing at pre-screening and tissue
 banking.

 -  Patients should complete a pre-screening biomarker analysis and should fulfill the
 following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family
 receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should
 show EGFR (Epidermal Growth Factor Receptor) amplification.

 -  Further inclusion criteria apply

 Exclusion criteria:

 -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment

 -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy
 or investigational agents within 4 weeks prior to the start of study treatment or
 prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first

 -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or
 leptomeningeal carcinomatosis

 -  Further exclusion criteria apply