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Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

NCT02780687

Description:

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 mutations or ERBB2 amplifications (Cohort A), and EGFR 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).

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
  • Official Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: 1200.261
  • SECONDARY ID: 2015-005427-10
  • NCT ID: NCT02780687

Conditions

  • Urologic Neoplasms

Interventions

DrugSynonymsArms
AfatinibAfatinib

Purpose

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 mutations or ERBB2 amplifications (Cohort A), and EGFR 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).

Trial Arms

NameTypeDescriptionInterventions
AfatinibExperimental
  • Afatinib

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival at 6 months in Cohort A (defined as the proportion of patients who does not show disease progression by the 24-week tumour assessment).
Time Frame:24 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR) in Cohort A, defined as number of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.
Time Frame:From Baseline to disease progression (up to 2 years)
Safety Issue:
Description:
Measure:Progression free survival (PFS) in Cohort A, defined as the time from first drug administration to the date of disease progression, or date of death whichever is earlier
Time Frame:Starting with first drug administration and until up to 2 years for each patient
Safety Issue:
Description:
Measure:Overall Survival (OS) in Cohort A, defined as the time from first drug administration to the date of death
Time Frame:From first drug administration to date of death (up to 5 years)
Safety Issue:
Description:
Measure:Disease Control Rate (DCR) in Cohort A, defined as complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (NN) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1
Time Frame:From first drug administration to disease progression (up to 2 years)
Safety Issue:
Description:
Measure:Duration of objective response (DOR) in Cohort A, according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1
Time Frame:From first drug administration to disease progression (up to 2 years)
Safety Issue:
Description:
Measure:Tumour shrinkage in Cohort A, measured as the maximum percentage decrease from baseline sum of target lesion diameters after treatment until disease progression
Time Frame:From first drug administration to disease progression (up to 2 years)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

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