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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007097-38 | EudraCT Number | EudraCT |
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The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 | Experimental | once daily taken orally |
|
| Cetuximab | Active Comparator | once every week by intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | experimental drug taken once daily orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment | Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates. | From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments | Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover. |
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Inclusion criteria:
1. Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
9. Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.28.0010 Boehringer Ingelheim Investigational Site | Stanford | California | United States | |||
| 1200.28.0001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25057165 | Derived | Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. |
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Open-label randomized, cross-over study. 124 patients were randomised. 3 patients were not treated, 1 in Afatinib arm and 2 in Cetuximab arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 50 mg / Cetuximab 250mg/m2 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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| Cetuximab |
| Drug |
active comparator administered weekly intravenously |
|
| From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment. |
| Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment). | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment). | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment) | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria. | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
| Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment) | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria. | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
| Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1 | Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1 | Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2 | Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria. | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
| Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1 | Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1 | Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria. | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
| Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2 | Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria. | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
| Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2 | Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria. | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
| Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment | PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial. Median is calculated from the Kaplan-Meier curve for each treatment group. | From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover. |
| Progression Free Survival (PFS) After Crossover Based on Investigator Assessment | PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial. Median is calculated from the Kaplan-Meier curve for each treatment group. | From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover. |
| Overall Survival (OS) | OS is defined as time from randomisation to death. Median is calculated from the Kaplan-Meier curve for each treatment group. | From randomisation to data cut-off date. |
| Time to Deterioration in HRQoL - Stage 1 | Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35). Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:
| From randomisation to deterioration in HRQoL scores before crossover. |
| Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function | Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial. | First administration of trial medication until 28 days after last drug administration |
| Incidence and Intensity of Adverse Events With Grading According CTCAE | Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0). | First administration of trial medication until 28 days after last drug administration |
| Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15) | Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15. Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2. | Day 15 |
| Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29) | Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29. Note: At day 29, values for afatinib 40 mg no values reported in stage 2. | Day 29 |
| Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57) | Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57. | Day 57 |
| Chicago |
| Illinois |
| United States |
| 1200.28.0005 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1200.28.0011 Boehringer Ingelheim Investigational Site | Harvey | Illinois | United States |
| 1200.28.0022 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| 1200.28.0024 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 1200.28.0012 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan | United States |
| 1200.28.0021 Boehringer Ingelheim Investigational Site | Saint Joseph | Michigan | United States |
| 1200.28.0016 Boehringer Ingelheim Investigational Site | Rochester | Minnesota | United States |
| 1200.28.0002 Boehringer Ingelheim Investigational Site | Jackson | Mississippi | United States |
| 1200.28.0006 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| 1200.28.0008 Boehringer Ingelheim Investigational Site | New Hyde Park | New York | United States |
| 1200.28.0017 Boehringer Ingelheim Investigational Site | Chapel Hill | North Carolina | United States |
| 1200.28.0004 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States |
| 1200.28.0013 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1200.28.0007 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1200.28.0009 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States |
| 1200.28.0020 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States |
| 1200.28.0030 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1200.28.0031 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1200.28.0032 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1200.28.0062A Boehringer Ingelheim Investigational Site | Alès | France |
| 1200.28.0062B Boehringer Ingelheim Investigational Site | Alès | France |
| 1200.28.0059A Boehringer Ingelheim Investigational Site | Avignon | France |
| 1200.28.0052A Boehringer Ingelheim Investigational Site | Lille | France |
| 1200.28.0051A Boehringer Ingelheim Investigational Site | Lyon | France |
| 1200.28.0050A Boehringer Ingelheim Investigational Site | Montpellier | France |
| 1200.28.0058A Boehringer Ingelheim Investigational Site | Nîmes | France |
| 1200.28.0061A Boehringer Ingelheim Investigational Site | Poitiers | France |
| 1200.28.0055G Boehringer Ingelheim Investigational Site | Rouen | France |
| 1200.28.0040 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1200.28.0044 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1200.28.0043 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1200.28.0042 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1200.28.0045 Boehringer Ingelheim Investigational Site | Santander | Spain |
| 1200.28.0041 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| Cetuximab 250 mg/m2 / Afatinib 50 mg |
Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Stage 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 50 mg / Cetuximab 250mg/m2 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. |
| BG001 | Cetuximab 250 mg/m2 / Afatinib 50 mg | Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2 |
| 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 |
| ||||||||||||||||
| Prior chemotherapies (CT)for recurrent/metastatic disease (R/M) | Number | Number of participants |
| ||||||||||||||||
| Baseline sum of longest diameters (SLD) of target lesions by investigator assessments | Baseline measures were available for only 61 patients in the Afatinib/Cetuximab group and only 60 patients in the Cetuximab/Afatinib group | Mean | Standard Deviation | millimeters |
|
| 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 | Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment | Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates. | Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not. However, patients without baseline or post-baseline tumor measurements were excluded. | Posted | Mean | Standard Error | millimeter | From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1. |
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| Secondary | Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments | Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover. | Patients treated in stage 2 : This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm. | Posted | Mean | Standard Deviation | millimeters | From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment. |
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| Secondary | Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment). | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria. | Randomised set (RS). | Posted | Number | Number of participants | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment). | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria. | Randomised set (RS). | Posted | Number | Number of participants | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment) | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria. | Patients treated in Stage 2 | Posted | Number | Number of participants | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
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| Secondary | Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment) | Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria. | Patients treated in Stage 2 | Posted | Number | Number of participants | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
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| Secondary | Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1 | Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1. | Randomised set (RS). | Posted | Number | Number of participants | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1 | Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria. | Randomised set (RS). | Posted | Number | Number of participants | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2 | Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria. | Patients treated in Stage 2 | Posted | Number | Number of participants | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
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| Secondary | Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1 | Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria. | Randomised Set (RS) | Posted | Mean | Standard Deviation | Weeks | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1 | Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria. | Randomised Set (RS) | Posted | Mean | Standard Deviation | Weeks | Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment |
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| Secondary | Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2 | Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria. | patients treated in stage 2 | Posted | Mean | Standard Deviation | Weeks | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
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| Secondary | Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2 | Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria. | patients treated in stage 2 | Posted | Mean | Standard Deviation | Weeks | Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment |
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| Secondary | Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment | PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial. Median is calculated from the Kaplan-Meier curve for each treatment group. | Randomised set (RS). | Posted | Median | 95% Confidence Interval | weeks | From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover. |
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| Secondary | Progression Free Survival (PFS) After Crossover Based on Investigator Assessment | PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial. Median is calculated from the Kaplan-Meier curve for each treatment group. | Patients treated in stage 2 | Posted | Median | 95% Confidence Interval | weeks | From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover. |
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| Secondary | Overall Survival (OS) | OS is defined as time from randomisation to death. Median is calculated from the Kaplan-Meier curve for each treatment group. | Randomised set (RS). | Posted | Median | 95% Confidence Interval | Weeks | From randomisation to data cut-off date. |
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| Secondary | Time to Deterioration in HRQoL - Stage 1 | Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35). Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:
| Randomised Set (RS) | Posted | Median | 95% Confidence Interval | months | From randomisation to deterioration in HRQoL scores before crossover. |
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| Secondary | Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function | Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial. | Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm. | Posted | Number | number of participants | First administration of trial medication until 28 days after last drug administration |
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| Secondary | Incidence and Intensity of Adverse Events With Grading According CTCAE | Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0). | Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm. | Posted | Number | percentage of participants | First administration of trial medication until 28 days after last drug administration |
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| Secondary | Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15) | Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15. Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2. | Pharmacokinetic Set (PK): The PK analysis was based on all patients who were treated with afatinib and who had evaluable plasma concentration data, which consisted of data for 60 patients in Stage 1 and 35 patients in Stage 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 15 |
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| Secondary | Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29) | Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29. Note: At day 29, values for afatinib 40 mg no values reported in stage 2. | Pharmacokinetic Set (PK) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57) | Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57. | Pharmacokinetic Set (PK) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 57 |
|
|
1493 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 | Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1 | Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2. | 26 | 60 | 59 | 60 | ||
| EG001 | Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. | 18 | 36 | 34 | 36 | ||
| EG002 | Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2 | Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2. | 13 | 32 | 29 | 32 | ||
| EG003 | Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. | 36 | 61 | 61 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Endocarditis noninfective | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | 16.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 16.1 | Systematic Assessment |
| |
| Chills | General disorders | 16.1 | Systematic Assessment |
| |
| Face oedema | General disorders | 16.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 16.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 16.1 | Systematic Assessment |
| |
| Pain | General disorders | 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 16.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 16.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Meningitis staphylococcal | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Toxic shock syndrome | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Linitis plastica | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 16.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | 16.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Gastrointestinal tube insertion | Surgical and medical procedures | 16.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 16.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 16.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infectio | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 16.1 | 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 | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
Not provided
Not provided
| Patient refused to continue study meds |
|
| Other than stated above |
|
| Male |
|
| No |
|
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| Participants |
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| Units |
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| Afatinib 50 mg - Stage 2 |
Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2 |
| OG003 | Cetuximab mg/m2 - Stage 2 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. |
|
|
| OG003 | Cetuximab mg/m2 - Stage 2 | Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2. |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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