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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007284-17 | EudraCT Number |
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This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD), safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor receptor(EGFR)inhibitor) to be used in combination with:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen U | Experimental | BIBW2992 + Radiotherapy |
|
| Regimen M | Experimental | BIBW2992 + Temozolomide + Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Investigator Defined Dose Limiting Toxicities (DLT) During the RT Phase | Adverse event (AE) related to afatinib with any one criteria; Hematological: Common terminology criteria for adverse events (CTCAE) Grade 4 neutropenia (Absolute neutrophil count, including bands <500/cubic millimeter (mm³)) for >7 days, CTCAE Grade 3 or 4 neutropenia of any duration associated with fever >38.3 Celsius, CTCAE Grade 3 thrombocytopenia (platelet count <50000 - 25000/mm³), All other toxicities of CTCAE Grade ≥3 leading interruption of treatment > 14 days. Non-hematological: CTCAE Grade ≥3 nausea or vomiting despite appropriate use of standard anti-emetics for ≥3 days, CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for ≥3 days, CTCAE Grade ≥3 rash despite standard medical management and lasting >7 days, CTCAE Grade ≥2 cardiac left ventricular function, CTCAE Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria or decrease in glomerular filtration rate, All other toxicities of CTCAE Grade ≥3. | 6 weeks |
| Maximum Tolerated Dose (MTD) of Afatinib | The MTD was defined as the highest afatinib dose level, at which no more than 1 out of 6 patients experienced drug-related DLT, i.e. the highest afatinib dose with a DLT incidence ≤17%. A separate MTD was determined for afatinib and RT (Regimen U), and for afatinib, TMZ, and RT (Regimen M). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0) | Incidence and intensity of adverse events (AE) according to Common Terminology Criteria of Adverse Events (CTCAE v.3.0). The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks |
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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 |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom | |||
| Ninewells Hospital & Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34787778 | Derived | Saran F, Welsh L, James A, McBain C, Gattamaneni R, Jefferies S, Harris F, Pemberton K, Schaible J, Bender S, Cseh A, Brada M. Afatinib and radiotherapy, with or without temozolomide, in patients with newly diagnosed glioblastoma: results of a phase I trial. J Neurooncol. 2021 Dec;155(3):307-317. doi: 10.1007/s11060-021-03877-6. Epub 2021 Nov 17. |
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All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
This is phase I, open-label, non-randomised, uncontrolled dose-escalation trial using a rule-based 3+3 design and patient stratification to explore safety of combining afatinib and radiotherapy with or without temozolomide in newly diagnosed Glioblastoma multiforme (GBM)
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2017 | Sep 4, 2018 |
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| Radiotherapy | Procedure | Day 1 to day 42 |
|
| BIBW2992 | Drug | Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT |
|
| Radiotherapy | Procedure | Day 1 to day 42 |
|
| BIBW2992 | Drug | Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT |
|
| The Objective Tumour Response According to the Macdonald Criteria | Objective response was defined as a best overall response of complete response (CR) or partial response (PR). The best overall response was the best overall response to trial medication according to the Macdonald criteria recorded since the first administration of trial medication and until the earliest of disease progression, death, or start of further anti-cancer treatment. Tumour response was assessed based on local radiological image evaluation by the investigators according to the Macdonald criteria: Complete Response (CR): Disappearance of all enhancing tumour on consecutive Magnetic resonance imaging (MRI) scans at least 28 days apart, off steroids, and neurologically stable or improved. Partial Response (PR): At least 50% reduction in size of enhancing tumour on consecutive MRI scans at least 28 days apart, steroids stable or reduced, and neurologically stable or improved. | From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks |
| Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29 | Concentration of afatinib in plasma at steady state pre-dose (Cpre,ss) on days 8, 15 and 29. | Pharmacokinetic blood sample were taken at 5 minutes before drug on days 8, 15 and 29 and 1, 3 and 6 hours after drug administration on day 15 |
| Dundee |
| DD1 9SY |
| United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| The Christie Hospital | Manchester | M20 4BX | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| FG001 | Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| FG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| FG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| FG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| Discontinued Afatinib Before/on Day 42 | Discontinued afatinib before or at the end of the concomitant treatment period (i.e. on day 42). |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS): Patients who received at least 1 dose of trial medication were included in the treated set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| BG001 | Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| BG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| BG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| BG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| BG005 | 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 | Treated Set | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Treated Set | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Ethnicity was not reported in this trial | Treated Set | 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 Patients With Investigator Defined Dose Limiting Toxicities (DLT) During the RT Phase | Adverse event (AE) related to afatinib with any one criteria; Hematological: Common terminology criteria for adverse events (CTCAE) Grade 4 neutropenia (Absolute neutrophil count, including bands <500/cubic millimeter (mm³)) for >7 days, CTCAE Grade 3 or 4 neutropenia of any duration associated with fever >38.3 Celsius, CTCAE Grade 3 thrombocytopenia (platelet count <50000 - 25000/mm³), All other toxicities of CTCAE Grade ≥3 leading interruption of treatment > 14 days. Non-hematological: CTCAE Grade ≥3 nausea or vomiting despite appropriate use of standard anti-emetics for ≥3 days, CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for ≥3 days, CTCAE Grade ≥3 rash despite standard medical management and lasting >7 days, CTCAE Grade ≥2 cardiac left ventricular function, CTCAE Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria or decrease in glomerular filtration rate, All other toxicities of CTCAE Grade ≥3. | Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined. | Posted | Number | Participants | 6 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence and Intensity of Adverse Events (AE) According to Common Terminology Criteria of Adverse Events (CTCAE v.3.0) | Incidence and intensity of adverse events (AE) according to Common Terminology Criteria of Adverse Events (CTCAE v.3.0). The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE). | Treated Set | Posted | Number | Participants | From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks |
| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) of Afatinib | The MTD was defined as the highest afatinib dose level, at which no more than 1 out of 6 patients experienced drug-related DLT, i.e. the highest afatinib dose with a DLT incidence ≤17%. A separate MTD was determined for afatinib and RT (Regimen U), and for afatinib, TMZ, and RT (Regimen M). | Treated Set (TS); 3 patients were not evaluable for the determination of the maximum tolerated dose replaced in regimen M. 7 patients were excluded from the Afatinib 40 mg arm regimen U count as these were part of the expansion phase after the Maximum Tolerated Dose (MTD) had been determined. | Posted | Number | Milligram (mg) | 6 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Objective Tumour Response According to the Macdonald Criteria | Objective response was defined as a best overall response of complete response (CR) or partial response (PR). The best overall response was the best overall response to trial medication according to the Macdonald criteria recorded since the first administration of trial medication and until the earliest of disease progression, death, or start of further anti-cancer treatment. Tumour response was assessed based on local radiological image evaluation by the investigators according to the Macdonald criteria: Complete Response (CR): Disappearance of all enhancing tumour on consecutive Magnetic resonance imaging (MRI) scans at least 28 days apart, off steroids, and neurologically stable or improved. Partial Response (PR): At least 50% reduction in size of enhancing tumour on consecutive MRI scans at least 28 days apart, steroids stable or reduced, and neurologically stable or improved. | Treated Set | Posted | Number | Participants | From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Afatinib in Plasma at Steady State Pre-dose on Days 8, 15 and 29 | Concentration of afatinib in plasma at steady state pre-dose (Cpre,ss) on days 8, 15 and 29. | Treated Set; only evaluable patients were included in the pharmacokinetic analysis | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pharmacokinetic blood sample were taken at 5 minutes before drug on days 8, 15 and 29 and 1, 3 and 6 hours after drug administration on day 15 |
|
From the first administration of trial medication until 4 weeks after the last administration of trial medication, up to approximately 338 weeks
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Afatinib 20 Milligram, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 20 milligram (mg) film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray (Gy)) plus Temozolomide (TMZ) 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. | 0 | 7 | 4 | 7 | 7 | 7 |
| EG001 | Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. | 0 | 6 | 5 | 6 | 6 | 6 |
| EG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. | 0 | 7 | 3 | 7 | 6 | 7 |
| EG003 | Total - Regimen M | Patients were administered Afatinib 20/30/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. | 0 | 20 | 12 | 20 | 19 | 20 |
| EG004 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. | 3 | 13 | 10 | 13 | 13 | 13 |
| EG006 | Total - Regimen U | Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. | 3 | 16 | 12 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Grip strength decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| QRS axis abnormal | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cells urine | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diet refusal | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Clumsiness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hemianopia homonymous | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Orchitis noninfective | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Perineal erythema | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2011 | Sep 4, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D000577 | Amides |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| OG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| OG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| OG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| OG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
|
|
Patients were administered Afatinib 20/40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
|
|
| OG001 | Afatinib 30 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| OG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| OG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| OG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
|
|
Patients were administered Afatinib 30 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first.
| OG002 | Afatinib 40 mg, Radiotherapy + Temozolomide - Regimen M | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray) plus Temozolomide 75 milligrams per square meter (mg/m2) capsules continuous daily oral dosing. In the maintenance phase after RT, patients stopped TMZ for 4 weeks and restarted TMZ at 150 mg/m2 in cycle 1 and 200 mg/m2 in cycles 2 to 6 on days 1 to 5 of 28-day treatment cycles. Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily after RT. Dose reductions of Afatinib were allowed if 40 mg or 30 mg were not tolerated. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. |
| OG003 | Afatinib 20 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 20 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
| OG004 | Afatinib 40 mg, Radiotherapy - Regimen U | Patients were administered Afatinib 40 mg film-coated tablet once daily orally plus radiotherapy (RT) i.e. focal radiation at a dose of 2 Gray per fraction on 5 days per week for 6 weeks (RT phase) (total dose of 60 Gray). Patients were administered Afatinib 40 milligram (mg) film-coated tablet once daily in the maintenance phase after RT. The treatment duration was until tumour progression or occurrence of undue adverse reactions, whichever occurred first. Dose reductions were allowed if 40 mg or 30 mg afatinib were not tolerated. |
|
|
|
|