Afatinib phase II trial in urothelial cancer patients with HER2/3 mutations

Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation. - Afatinib Phase II trial in HER2/3 mutated urothelial cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005427-10-ES

Enrollment

350

Registered

2016-03-18

Start date

2016-04-29

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation MedDRA version: 18.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: GIOTRIF Product Name: Afatinib Product Code: BIBW 2992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: aftinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

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 criteria apply

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): 1: Objective response rate (ORR), defined as number of complete response (CR) or partial response (PR) according to RECIST 1.1. 2: Progression free survival (PFS). 3: Overall Survival (OS) 4: Disease Control Rate (DCR) 5: Duration of objective response (DOR) 6: Tumour shrinkage ; Timepoint(s) of evaluation of this end point: 1: From Baseline to End of Trial 2: From first drug administration to disease progression 3: From first drug adminitration to date of death 4: From first drug administration to disease progression 5: From first drug administration to disease progression 6: From first drug administration to disease progression	—

Measure

Time frame

Secondary end point(s): 1: Objective response rate (ORR), defined as number of complete response (CR) or partial response (PR) according to RECIST 1.1. 2: Progression free survival (PFS). 3: Overall Survival (OS) 4: Disease Control Rate (DCR) 5: Duration of objective response (DOR) 6: Tumour shrinkage ; Timepoint(s) of evaluation of this end point: 1: From Baseline to End of Trial 2: From first drug administration to disease progression 3: From first drug adminitration to date of death 4: From first drug administration to disease progression 5: From first drug administration to disease progression 6: From first drug administration to disease progression

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Countries

France, Spain

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+3493404-5100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026