18 and older, any sex, with Urologic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Progression-free Survival at Six Months (PFS6) in Cohort APrimary· From start of treatment till assesment at week 24.
Progression-free survival at 6 months for Cohort A was defined as the number of patients who were alive and without disease progression at 24-week tumour assessment. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated. Progress
Group
Value
95% CI
Cohort A
4
Number of Participants With Confirmed Objective Response (ORR) in Cohort ASecondary· Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Confirmed objective response by investigator review for Cohort A was defined as the number of participants with confirmed complete response (CR, disappearance of all target lesions) or confirmed partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be perform
Group
Value
95% CI
Cohort A
2
Progression-free Survival (PFS) in Cohort ASecondary· Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Progression-free survival was defined as the time (months) from the date of the first afatinib administration to the date of disease progression or death (if the patient died without progression). The date of progression for the primary analyses was determined based on investigator assessment. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to RECIST version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already ha
Group
Value
95% CI
Cohort A
9.8
7.9 – 16.0
Overall Survival (OS) in Cohort ASecondary· From start of treatment of afatinib until death from any cause, i.e. up to approximately 20 Months.
Overall survival (OS) defined as the time from start of treatment of afatinib until death from any cause.
Group
Value
95% CI
Cohort A
30.1
17.4 – 47.0
Number of Participants With Disease Control (DCR) in Cohort ASecondary· Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Disease control was calculated as the number of participants with complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD), or stable disease (SD, neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum of diameters (SoD), nor sufficient increase to qualify for PD (Progression) taking as reference the smallest SoD since the treatment started). Tumour response was assessed based on local radiological image (Computerised tomography (CT) o
Group
Value
95% CI
Cohort A
17
Cohort A
17
Duration of Disease Control in Cohort ASecondary· Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
For patients with disease control, duration of disease control was defined as the time from afatinib treatment start to disease progression (or death if the patient died before progression).
Disease control was defined as a having a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD), or stable disease (SD, neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum of diameters (SoD), nor sufficient increase to qualify for PD taking
Group
Value
95% CI
Cohort A
22.7
15.1 – 36.1
Number of Patients With Tumour Shrinkage in Cohort ASecondary· Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Number of patients with tumour shrinkage, tumour shrinkage from baseline was defined by the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was
Group
Value
95% CI
Cohort A
9
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of first drug administration till the end of treatment + 30 days (REP), up to approximately 20 Months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A
Serious: 15/34 (44%)
Deaths: 26/34
Cohort B
Serious: 6/8 (75%)
Deaths: 7/8
Serious adverse events (30 terms)
Reaction
System
Cohort A
Cohort B
Diarrhoea
Gastrointestinal disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Acute coronary syndrome
Cardiac disorders
—
—
Cardiac failure
Cardiac disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Pain
General disorders
—
—
Pyrexia
General disorders
—
—
Escherichia pyelonephritis
Infections and infestations
—
—
Infected skin ulcer
Infections and infestations
—
—
Influenza
Infections and infestations
—
—
Pelvic abscess
Infections and infestations
—
—
Respiratory tract infection
Infections and infestations
—
—
Urinary tract infection bacterial
Infections and infestations
—
—
Cachexia
Metabolism and nutrition disorders
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Fistula
Musculoskeletal and connective tissue disorders
—
—
Groin pain
Musculoskeletal and connective tissue disorders
—
—
Musculoskeletal disorder
Musculoskeletal and connective tissue disorders
—
—
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) 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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 18 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02780687.