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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011996-59 | EudraCT Number | EudraCT |
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This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 | Experimental | Patients receive BIBW 2992 tablets once daily |
|
| Cetuximab | Active Comparator | Patients receive cetuximab intravenously once a week, every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response | Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied. | Baseline till progression or death, whichever came first, assessed up to 23 months |
| Percentage of Participants With Disease Control (DC) | Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied. | Baseline till progression or death, whichever came first, assessed up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method. | Baseline till progression or death, whichever came first, assessed up to 23 months |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.74.44001 Boehringer Ingelheim Investigational Site | Bournemouth | United Kingdom | ||||
| 1200.74.44005 Boehringer Ingelheim Investigational Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib (Wild-type) | Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. |
| FG001 | Cetuximab (Wild-type) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetuximab | Drug | Patients receive cetuximab intravenously, once a week, every week |
|
| Overall Survival (OS) Time | OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method. | Baseline till death, assessed up to 23 months |
| Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) | Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8. | day 8 |
| Bristol |
| United Kingdom |
| 1200.74.44006 Boehringer Ingelheim Investigational Site | Cambridge | United Kingdom |
| 1200.74.44003 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom |
| 1200.74.44009 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1200.74.44012 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
| 1200.74.44007 Boehringer Ingelheim Investigational Site | Northwood | United Kingdom |
| 1200.74.44013 Boehringer Ingelheim Investigational Site | Nottingham | United Kingdom |
| 1200.74.44011 Boehringer Ingelheim Investigational Site | Poole | United Kingdom |
| 1200.74.44010 Boehringer Ingelheim Investigational Site | Sheffield | United Kingdom |
| 1200.74.44008 Boehringer Ingelheim Investigational Site | Southampton | United Kingdom |
| 1200.74.44004 Boehringer Ingelheim Investigational Site | Sutton, Surrey | United Kingdom |
| 1200.74.44002 Boehringer Ingelheim Investigational Site | Truro | United Kingdom |
Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer. |
| FG002 | Afatinib (Mutated) | Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Afatinib (Wild-type) | Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. |
| BG001 | Cetuximab (Wild-type) | Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer. |
| BG002 | Afatinib (Mutated) | Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. |
| BG003 | 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 | Percentage of Participants With Objective Response | Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied. | Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours. | Posted | Number | Percentage of Participants | Baseline till progression or death, whichever came first, assessed up to 23 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Disease Control (DC) | Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied. | Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline till progression or death, whichever came first, assessed up to 23 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method. | Randomised set for wild-type group and treated set for mutated group. | Posted | Median | 95% Confidence Interval | Days | Baseline till progression or death, whichever came first, assessed up to 23 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Time | OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method. | Randomised set for wild-type group and treated set for mutated group. | Posted | Median | 95% Confidence Interval | Days | Baseline till death, assessed up to 23 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) | Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8. | Randomised set for wild-type group and treated set for mutated group. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | day 8 |
|
|
First administration of trial medication until 28 days after last administration of trial medication
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Afatinib (Wild-type) | Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. | 15 | 36 | 35 | 36 | ||
| EG001 | Cetuximab (Wild-type) | Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer. | 5 | 14 | 14 | 14 | ||
| EG002 | Afatinib (Mutated) | Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated. | 18 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Quality of life decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Scintillating scotoma | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 15.0 | 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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|