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Afatinib* is currently being investigated in Phase II trials in patients with advanced urothelial carcinoma; this section provides an overview of these trials.
Afatinib trials in urothelial cancer
In study 1200.171, a Phase II trial in patients with advanced platinum-refractory urothelial cancer, afatinib demonstrated significant anti-tumour activity in patients with HER2 or ErbB3 alterations, with no unexpected toxicities.1,2 A Phase II trial in patients with advanced/metastatic urothelial tract carcinoma with ErbB Family receptor deregulation after failure of platinum-based chemotherapy is currently recruiting.3 Patients are eligible if they have urothelial cancer harbouring ErbB2/ErbB3 mutations or ErbB2 amplification (Cohort A), or EGFR amplification (Cohort B). Cohorts A and B will be analysed separately; the primary endpoint is PFS at 6 months in Cohort A, however all secondary endpoints, safety and biomarker assessments will be analysed for both cohorts.
OS, overall survival; PFS, progression-free survival.
ClinicalTrials.gov. NCT02122172. http://clinicaltrials.gov/ct2/show/NCT02122172. Accessed: July 2017.
Choudhury NJ, et al. J Clin Oncol 2016;34(18):2165-71.
ClinicalTrials.gov. NCT02780687. http://clinicaltrials.gov/ct2/show/NCT02780687. Accessed: July 2017.
*Afatinib is approved in more than 80 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information. Afatinib is being investigated in urothelial carcinoma (UC) and head and neck squamous cell carcinoma (HNSCC) and is not approved for these uses. The efficacy and safety of afatinib in UC and HNSCC have not been established.
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