LUX-Bladder 1: Phase II Open Label Single Arm Exploratory Trial of Oral Afatinib Monotherapy Following Platinum Failure for Patients With Advanced/Metastatic Urothelial Tract Carcinoma With Genetic Alterations in ERBB Receptors.


Condition: Urologic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02780687

Sponsor: Boehringer Ingelheim

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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:

  • 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

View trial on ClinicalTrials.gov