Afatinib phase II trial in urothelial cancer patients with HER2/3 mutations
- Conditions
- patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulationMedDRA version: 18.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005427-10-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
-recurrent or metastatic urothelial cancer
-patients must have failed prior platinum based treatment (adjuvant or 1st line)
-tumour sample for HER2/3 mutation testing and/or assessment of markers to determine basal histology must be available
Further criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
-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 criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess efficacy of afatinib in urothelial cancer patients based on PFS;Secondary Objective: objective response, best recist assessment, safety, survival;Primary end point(s): 1: 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).;Timepoint(s) of evaluation of this end point: 1: 24 weeks
- Secondary Outcome Measures
Name Time Method