Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002613-43 | EudraCT Number | EudraCT |
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Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.
The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. BIBW 2992-cisplatin-paclitaxel | Experimental | daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel |
|
| B. BIBW 2992-cisplatin-5FU | Experimental | daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) | Number of participants with DLT in the first cycle (21 days) for the determination of the MTD. | 21 days |
| Maximum Tolerated Dose (MTD) for Regimen A and Regimen B | The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Objective Response | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR). | Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days) |
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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 |
|---|---|---|---|---|---|---|
| 1200.37.3202 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1200.37.3201 Boehringer Ingelheim Investigational Site |
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pac175 + Cis50 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG001 | Pac175 + Cis75 + Afatinib20 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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| BIBW 2992 | Drug | low to high dose, daily |
|
| Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum concentration of afatinib in plasma at steady state | 0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration |
| Edegem |
| Belgium |
| 1200.37.3203 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG002 | Pac175 + Cis75 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG003 | Pac175 + Cis75 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG004 | Pac175 + Cis75 + Afatinib50 | Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG005 | Cis75 + 5FU750 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG006 | Cis75 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG007 | Cis75 + 5FU750 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG008 | Cis100 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| FG009 | Cis100 + 5FU1000 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pac175 + Cis50 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG001 | Pac175 + Cis75 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG002 | Pac175 + Cis75 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG003 | Pac175 + Cis75 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG004 | Pac175 + Cis75 + Afatinib50 | Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG005 | Cis75 + 5FU750 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG006 | Cis75 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG007 | Cis75 + 5FU750 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG008 | Cis100 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG009 | Cis100 + 5FU1000 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| BG010 | 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) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) | Number of participants with DLT in the first cycle (21 days) for the determination of the MTD. | Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | Participants | 21 days |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) for Regimen A and Regimen B | The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1. | Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | mg/m^2 | 21 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Objective Response | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR). | Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. | Posted | Number | Participants | Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss) | Cmax,ss represents the maximum concentration of afatinib in plasma at steady state | The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration |
|
First administration of trial medication until 28 days after last administration of trial medication
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 | Pac175 + Cis50 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 1 | 3 | 3 | 3 | ||
| EG001 | Pac175 + Cis75 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 5 | 6 | 6 | 6 | ||
| EG002 | Pac175 + Cis75 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 4 | 5 | 5 | 5 | ||
| EG003 | Pac175 + Cis75 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 7 | 11 | 11 | 11 | ||
| EG004 | Pac175 + Cis75 + Afatinib50 | Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 1 | 1 | 1 | 1 | ||
| EG005 | Cis75 + 5FU750 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 2 | 3 | 3 | 3 | ||
| EG006 | Cis75 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 6 | 7 | 7 | 7 | ||
| EG007 | Cis75 + 5FU750 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 3 | 3 | 3 | 3 | ||
| EG008 | Cis100 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 1 | 5 | 5 | 5 | ||
| EG009 | Cis100 + 5FU1000 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. | 3 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lip disorder | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Omphalitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Self esteem inflated | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nail pitting | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin fragility | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 13.1 | 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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| 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 |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
|
| OG003 | Pac175 + Cis75 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG004 | Pac175 + Cis75 + Afatinib50 | Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG005 | Cis75 + 5FU750 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG006 | Cis75 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG007 | Cis75 + 5FU750 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG008 | Cis100 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG009 | Cis100 + 5FU1000 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
|
|
Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG003 | Pac175 + Cis75 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG004 | Pac175 + Cis75 + Afatinib50 | Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG005 | Cis75 + 5FU750 + Afatinib20 | Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG006 | Cis75 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG007 | Cis75 + 5FU750 + Afatinib40 | Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG008 | Cis100 + 5FU750 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
| OG009 | Cis100 + 5FU1000 + Afatinib30 | Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity. |
|
|