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Afatinib in urothelial cancer after failure of platinum-based chemotherapy

A Phase II Study of Afatinib in Patients with Previously Treated Advanced/Metastatic Urothelial Cancer with Genetic Alterations in ErbB Receptors

A Phase II, open-label trial to assess the anti-tumour activity and safety of afatinib* monotherapy after failure of platinum-based chemotherapy in patients with urothelial cancer with:

  • ErbB2 or ErbB3 mutations or ErbB2 amplifications (Cohort A)
  • Epidermal growth factor receptor (EGFR) amplification-positive tumours (Cohort B)

Trial NCT02780687


Advanced/metastatic urothelial cancer with genetic alterations in ErbB receptors

Failure of platinum-based chemotherapy

No prior use of EGFR, ErbB2 or ErbB3 targeted treatment

Estimated N=80

Afatinib 40 mg Oral, once daily (cohorts A and B)


Primary outcome measure:

  • Progression-free survival (PFS) rate at 6 months in Cohort A


Key secondary outcome measure:

  • Objective response rate (ORR) in Cohort A


Further secondary outcome measures:

  • PFS in cohort A
  • Overall survival (OS) in Cohort A
  • Disease control rate (DCR) in Cohort A
  • Duration of objective response (DOR) in Cohort A
  • Tumour shrinkage in Cohort A


Further outcome measures:

  • PFS rate at 6 months in Cohort B
  • PFS in Cohort B
  • OS in Cohort B
  • ORR in Cohort B
  • DCR in Cohort B
  • DOR in Cohort B
  • Safety of afatinib as indicated by intensity and incidence of adverse events, graded according to US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Trial Status

Currently recruiting participants; active in France, Italy and Spain.


1 (Accessed: March 2018).

*Afatinib is being investigated in urothelial cancer (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.

© 2018 Boehringer Ingelheim International GmbH. All rights reserved.

Last updated: July 2018