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This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.
The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 low dose | Experimental | patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
|
| BIBW 2992 medium dose | Experimental | patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
|
| BIBW 2992 high dose | Experimental | patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
|
| BIBW 2992 low dose 6 day | Experimental | patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
|
| BIBW 2992 medium dose 6 day | Experimental | patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 low dose | Drug | patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set | Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2). | DLT were assessed during the first cycle (days 1-21) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set | Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2). | DLT were assessed during all cycles of treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.92.1001 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |||
| 1200.92.1002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25037863 | Derived | Chu QS, Sangha R, Hotte SJ, Sergenson G, Schnell D, Chand VK, Hirte HW. A phase I, dose-escalation trial of continuous- and pulsed-dose afatinib combined with pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1226-35. doi: 10.1007/s10637-014-0139-9. Epub 2014 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Afatinib 30 mg | Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992. |
| FG001 | Continuous Afatinib 40 mg | Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BIBW 2992 high dose 6 day | Experimental | patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m^2 on day 1 of 21 day cycle |
|
| BIBW 2992 high dose | Drug | patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| BIBW 2992 high dose 6 day | Drug | patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| pemetrexed | Drug | given intravenously on day 1 of a 21 day cycle |
|
| BIBW 2992 low dose 6 day | Drug | patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle |
|
| BIBW 2992 medium dose 6 day | Drug | patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle |
|
| BIBW 2992 medium dose | Drug | patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle |
|
| Objective Response (OR) |
Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1. Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD. |
| Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| Disease Control | Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1. | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| Progression Free Survival (PFS) | PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria. | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| Tumour Shrinkage | Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions. | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| Hamilton |
| Ontario |
| Canada |
| FG002 | Pulsed Afatinib 50 mg | Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992. |
| FG003 | Pulsed Afatinib 60 mg | Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992. |
| FG004 | Pulsed Afatinib 70 mg | Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set includes all randomized patients that received Afatinib or Pemetrexed
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Afatinib 30 mg | Continuous Afatinib 30 mg plus Pemetrexed |
| BG001 | Continuous Afatinib 40 mg | Continuous Afatinib 40 mg plus Pemetrexed |
| BG002 | Pulsed Afatinib 50 mg | Pulsed Afatinib 50 mg plus Pemetrexed |
| BG003 | Pulsed Afatinib 60 mg | Pulsed Afatinib 60 mg plus Pemetrexed |
| BG004 | Pulsed Afatinib 70 mg | Pulsed Afatinib 70 mg plus Pemetrexed |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set | Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2). | Treated Set includes all patients that received treatment of Afatinib or Pemetrexed that who were evaluable for MTD determination | Posted | Number | participants | DLT were assessed during the first cycle (days 1-21) |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set | Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2). | Treated Set includes all patients that received treatment of Afatinib or Pemetrexed | Posted | Number | participants | DLT were assessed during all cycles of treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response (OR) | Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1. Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD. | Treated Set includes all patients that received treatment of Afatinib or Pemetrexed | Posted | Number | participants | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control | Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1. | Treated Set includes all patients that received treatment of Afatinib or Pemetrexed | Posted | Number | participants | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria. | Treated Set includes all patients that received treatment of Afatinib or Pemetrexed | Posted | Median | 95% Confidence Interval | months | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Tumour Shrinkage | Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions. | Treated Set: all patients that received treatment of Afatinib or Pemetrexed and who were evaluated for the longest diameter of the target lesions. | Posted | Number | participants | Every 6 weeks before week 48 and every 12 weeks after week 48 until progression |
|
Starting with first administration of trial drug (Afatinib or Pemetrexed) and ending 28 days after the last administration of trial drug.
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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 | Continuous Afatinib 30 mg | Continuous Afatinib 30 mg plus Pemetrexed | 9 | 20 | 20 | 20 | ||
| EG001 | Continuous Afatinib 40 mg | Continuous Afatinib 40 mg plus Pemetrexed | 2 | 3 | 3 | 3 | ||
| EG002 | Pulsed Afatinib 50 mg | Pulsed Afatinib 50 mg plus Pemetrexed | 3 | 7 | 7 | 7 | ||
| EG003 | Pulsed Afatinib 60 mg | Pulsed Afatinib 60 mg plus Pemetrexed | 4 | 17 | 17 | 17 | ||
| EG004 | Pulsed Afatinib 70 mg | Pulsed Afatinib 70 mg plus Pemetrexed | 4 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Eye oedema | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Aptyalism | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Mass | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Thirst | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Omphalitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Penile discharge | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hangnail | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
Pulsed Afatinib 70 mg plus Pemetrexed |
|
|
| OG003 |
| Pulsed Afatinib 60 mg |
Pulsed Afatinib 60 mg plus Pemetrexed |
| OG004 | Pulsed Afatinib 70 mg | Pulsed Afatinib 70 mg plus Pemetrexed |
|
|
Pulsed Afatinib 70 mg plus Pemetrexed
|
|
Pulsed Afatinib 70 mg plus Pemetrexed |
|
|
Pulsed Afatinib 70 mg plus Pemetrexed |
|
|