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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010003-89 | EudraCT Number | EudraCT |
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Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 + Trastuzumab | Experimental | Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Load: 4mg/kg-maintain:2mg/kg/week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section. | 28 days |
| Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R) | The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR). | Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. |
Not provided
Inclusion criteria:
Exclusion criteria:
Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.68.44001 Boehringer Ingelheim Investigational Site | Brighton | United Kingdom | ||||
| 1200.68.44003 Boehringer Ingelheim Investigational Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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This was an open-label dose escalation study using a standard 3+3 dose escalation design, dose cohorts are presented here.
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 20mg + Herceptin | Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BIBW 2992 |
| Drug |
Increased dose cohorts from low dose to MTD |
|
| Number of Patients With Best Overall Response | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable. | Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. |
| Progression Free Survival (PFS) | PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates. | Baseline until disease progression, death or data cut-off. |
| Summary of Concentration of Afatinib in Plasma | Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss). | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
| Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
| Summary of Concentration of Herceptin in Plasma | Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29). | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
| Cambridge |
| United Kingdom |
| 1200.68.44005 Boehringer Ingelheim Investigational Site | Guildford | United Kingdom |
| 1200.68.44004 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | United Kingdom |
| 1200.68.44002 Boehringer Ingelheim Investigational Site | Truro | United Kingdom |
| Afatinib 30mg + Herceptin |
Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 20mg + Herceptin | Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit. |
| BG001 | Afatinib 30mg + Herceptin | Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Dose Limiting Toxicities (DLT) | Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section. | Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose. | Posted | Number | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R) | The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations. | TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose. | Posted | Number | mg | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR). | TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | Participants | Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Best Overall Response | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable. | TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | Participants | Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates. | TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Median | 95% Confidence Interval | Days | Baseline until disease progression, death or data cut-off. |
|
| |||||||||||||||||||||||||||||
| Secondary | Summary of Concentration of Afatinib in Plasma | Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss). | Patients with no data available for the relevant parameter and dose were excluded from analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
|
| |||||||||||||||||||||||||||||
| Secondary | Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) | tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state | Patients with no data available for the relevant parameter and dose were excluded from analysis. | Posted | Median | Full Range | hours | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
|
| |||||||||||||||||||||||||||||
| Secondary | Summary of Concentration of Herceptin in Plasma | Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29). | Patients with no data available for the relevant parameter and dose were excluded from analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing |
|
|
First administration of trial medication until 28 days after last administration of trial medication (up to 1296 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Afatinib 20mg + Herceptin | Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression. | 3 | 16 | 15 | 16 | ||
| EG001 | Afatinib 30mg + Herceptin | Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression. | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal 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 |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema mouth | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oral mucosal erythema | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Crepitations | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Secretion discharge | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Spinal pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tenderness | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 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 |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Breast discharge | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | 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 |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
MTD was determined at 20mg afatinib when 1/6 pat. had DLT (3+3 design). Upon expansion of MTD cohort to 18 pat. recruitment was stopped when 4/13 pat. had DLT. No lower afatinib dose could be tested as 20mg was the lowest dose formulation available.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Participants |
|
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| Participants |
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