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Clinical Trial Summary

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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02780687
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 2
Start date June 9, 2016
Completion date September 2, 2019

See also
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