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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001264-37 | EudraCT Number | EudraCT |
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The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 | Experimental | BIBW 2992 in EGFR FISH positive NSCLC patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiBW 2992 | Drug | BIBW 2992 in EGFR FISH positive NSCLC patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Objective Response | Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response (OR) Categorized by Time | Cumulative number of participants with objective response by time points with responders. | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.40.39011 Boehringer Ingelheim Investigational Site | Arezzo | Italy | ||||
| 1200.40.39007 Boehringer Ingelheim Investigational Site |
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First patient enrolled on December 23rd 2008 . Last patient enrolled on September 1st 2011. Patients were recruited in Oncology departments of Italian investigational sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 50mg | Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 50mg | Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Best Objective Response | Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. | Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
|
First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Afatinib 50mg | Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Duration of Confirmed Objective Response (OR) | Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival). | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
| Percentage of Participants With Disease Control (DC) | Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0. | Every 8 weeks until last response assessment 28NOV12 |
| Duration of Confirmed Disease Control | Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression. | Every 8 weeks until last response assessment 28NOV12 |
| Progression Free Survival (PFS) Time | Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death. | Every 8 weeks until last response assessment 28NOV12 |
| Overall Survival (OS) Time | Overall survival time is defined as time from the date of start of treatment to the date of death. | Baseline until last vital status assessment 17JUN13 |
| Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) | Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15. | Day 15 |
| Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder | The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs. | First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks |
| Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction | Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events. There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF). | First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks |
| Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status | Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below : 0 : Fully active, able to carry on all pre-disease performance without restriction.
Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included. | End Of Treatment, up until 190 weeks |
| Aviano (PN) |
| Italy |
| 1200.40.39013 Boehringer Ingelheim Investigational Site | Faenza (RA) | Italy |
| 1200.40.39003 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1200.40.39010 Boehringer Ingelheim Investigational Site | Livorno | Italy |
| 1200.40.39012 Boehringer Ingelheim Investigational Site | Lugo (RA) | Italy |
| 1200.40.39008 Boehringer Ingelheim Investigational Site | Modena | Italy |
| 1200.40.39005 Boehringer Ingelheim Investigational Site | Monza (MI) | Italy |
| 1200.40.39006 Boehringer Ingelheim Investigational Site | Padova | Italy |
| 1200.40.39002 Boehringer Ingelheim Investigational Site | Perugia | Italy |
| 1200.40.39004 Boehringer Ingelheim Investigational Site | Prato | Italy |
| 1200.40.39009 Boehringer Ingelheim Investigational Site | Ravenna | Italy |
| 1200.40.39001 Boehringer Ingelheim Investigational Site | Rozzano (MI) | Italy |
| Progressive disease |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Objective Response (OR) Categorized by Time | Cumulative number of participants with objective response by time points with responders. | Treated set (TS). | Posted | Number | percentage of participants | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
|
|
|
| Secondary | Duration of Confirmed Objective Response (OR) | Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival). | Treated set (TS). | Posted | Mean | Standard Deviation | Weeks | Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. |
|
|
|
| Secondary | Percentage of Participants With Disease Control (DC) | Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0. | Treated set (TS). | Posted | Number | 95% Confidence Interval | percentage of participants | Every 8 weeks until last response assessment 28NOV12 |
|
|
|
| Secondary | Duration of Confirmed Disease Control | Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression. | Treated set (TS). | Posted | Mean | Standard Deviation | Weeks | Every 8 weeks until last response assessment 28NOV12 |
|
|
|
| Secondary | Progression Free Survival (PFS) Time | Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death. | Treated set (TS). | Posted | Median | 95% Confidence Interval | Weeks | Every 8 weeks until last response assessment 28NOV12 |
|
|
|
| Secondary | Overall Survival (OS) Time | Overall survival time is defined as time from the date of start of treatment to the date of death. | Treated set (TS). | Posted | Median | 95% Confidence Interval | Weeks | Baseline until last vital status assessment 17JUN13 |
|
|
|
| Secondary | Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) | Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15. | Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data. Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 15 |
|
|
|
| Secondary | Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder | The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs. | Treated Set (TS). | Posted | Number | Percentage of participants | First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks |
|
|
|
| Secondary | Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction | Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events. There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF). | Treated Set (TS). | Posted | Number | percentage of participants | First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks |
|
|
|
| Secondary | Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status | Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below : 0 : Fully active, able to carry on all pre-disease performance without restriction.
Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included. | Treated set (TS). | Posted | Number | percentage of participants | End Of Treatment, up until 190 weeks |
|
|
|
| 35 |
| 69 |
| 66 |
| 69 |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Death | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Vomiting |
|
| Constipation |
|
| Abdominal pain |
|
| Abdominal pain upper |
|
| Cheilitis |
|
| Dyspepsia |
|
| Dysphagia |
|
| Abdominal distension |
|
| Dry mouth |
|
| Flatulence |
|
| Gastritis erosive |
|
| Odynophagia |
|
| Peritoneal haemorrhage |
|
| Rectal haemorrahage |
|
| Tongue Ulceration |
|
| Rash |
|
| Skin exfoliation |
|
| Dry skin |
|
| Nail disorder |
|
| Pruritus |
|
| Dermatitis acneiform |
|
| Alopecia |
|
| Granuloma skin |
|
| Hirsutism |
|
| Hypertrichosis |
|
| Nail discolouration |
|
| Night sweats |
|
| palmar-plantar erythrodysaesthesia syndrome |
|
| Skin fissures |
|
| Skin reaction |
|
| Title | Measurements |
|---|---|
|
| Blood bilirubin increased |
|
| Blood Creatine phosphokinase increased |
|
| Blood lactate dehydrogenase increased |
|
| Ejection fraction decreased |
|
| Gamma-glutamyltransferase increased |
|
| International normalised ratio increased |
|
| Transaminases increased |
|
| Weight decreased |
|
| Title | Measurements |
|---|
|
| 3 |
|
| 4 |
|
| Missing |
|