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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| afatinib and vinorelbine IV | Experimental | patient to receive 20mg or 40mg of po daily afatinib in combination with vinorelbine IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| afatinib 20mg | Drug | patient to receive afatinib low dose po daily in combination with vinorelbine iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course | DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined) | during 1st course |
| Drug-related Adverse Events | Number of patients with drug-related adverse events | during the treatment period or up to 28 days after the completion of drug administration, up to 730 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss for Afatinib | area under the plasma concentration-time curve following dose at steady state over the dosing interval τ | pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine") |
| Cmax,ss for Afatinib |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.84.003 Boehringer Ingelheim Investigational Site | Chuo-ku, Osaka, Osaka | Japan | ||||
| 1200.84.004 Boehringer Ingelheim Investigational Site |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1) | Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly |
| FG001 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly |
| FG002 | Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) | Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly |
| FG003 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1) | Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly |
| BG001 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2) |
| 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 | Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course | DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined) | Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine) | Posted | Number | participants | during 1st course |
|
during the treatment period or up to 28 days after the completion of drug administration, up to 730 days
Not provided
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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 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1) | Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | 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 |
MTD was not determined and below Cohort 2 due to DLTs likely related to vinorelbine. After the revised dose criteria for afatinib and vinorelbine were implemented, Cohort 3 was established as a recommended dose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| afatinib 40mg | Drug | patient to receive afatinib high dose po daily in combination with vinorelbine iv |
|
| vinorelbine IV 25 or 20mg/m2 | Drug | patient to receive standard dose vinorelbine once a week for four times per cycle |
|
maximum measured plasma concentration at steady state |
| pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine") |
| AUC0-∞ for Vinorelbine | area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity | predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib") |
| Cmax for Vinorelbine | maximum measured blood concentration | predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib") |
| Objective Tumour Response | According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." | Pre-treatment, every 8 weeks after start of study treatment, end of treatment |
| Kashiwa, Chiba |
| Japan |
| 1200.84.001 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1200.84.002 Boehringer Ingelheim Investigational Site | Sakyo-ku, Kyoto, Kyoto | Japan |
| Dose limiting toxicity |
|
| Other adverse events |
|
| Withdrawal by Subject |
|
Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
| BG002 | Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) | Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly |
| BG003 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) | Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly |
| OG003 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia |
|
|
| Secondary | AUCτ,ss for Afatinib | area under the plasma concentration-time curve following dose at steady state over the dosing interval τ | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine") |
|
|
|
| Secondary | Cmax,ss for Afatinib | maximum measured plasma concentration at steady state | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as "with Vinorelbine") and 20th dose (as "without Vinorelbine") |
|
|
|
| Secondary | AUC0-∞ for Vinorelbine | area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib") |
|
|
|
| Secondary | Cmax for Vinorelbine | maximum measured blood concentration | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as "with afatinib") and 1st dose (as "without afatinib") |
|
|
|
| Secondary | Objective Tumour Response | According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." | Treated set | Posted | Number | participants | Pre-treatment, every 8 weeks after start of study treatment, end of treatment |
|
|
|
| Primary | Drug-related Adverse Events | Number of patients with drug-related adverse events | Treated set | Posted | Number | participants | during the treatment period or up to 28 days after the completion of drug administration, up to 730 days |
|
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly | 4 | 5 | 5 | 5 |
| EG002 | Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a) | Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly | 0 | 3 | 3 | 3 |
| EG003 | Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3) | Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia | 2 | 6 | 6 | 6 |
| Cardiac tamponade | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Hepatic infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Extradural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vitreous floaters | Eye 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 |
|
| Cheilitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Malaise | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Amylase 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 creatine phosphokinase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
|
| Lipase 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 |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Arthralgia | 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 |
|
| 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 |
|
| Hypoaesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue 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 |
|
| 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 |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vasculitis | Vascular 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.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |