Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1891037 |
Not provided
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Not provided
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The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Tarceva or Iressa With EGFR Mutation | Experimental | HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening |
|
| Prior Tarceva or Iressa w/o EGFR Mutation | Experimental | HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening |
|
| No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Experimental | HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HKI-272 | Drug | 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer | Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. | From first dose date to progression/death or last tumor assessment, up to three years. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer | Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Puma | Biotechnology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Midwestern Regional Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prior Tarceva or Iressa With EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From first dose date to progression/death or last tumor assessment, up to three years. |
| Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer | Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. | From start date of response to first PD, assessed up to three years after the first randomization. |
| Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer | Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From first dose date to progression/death, assessed up to three years. |
| Zion |
| Illinois |
| 60099 |
| United States |
| Massachusetts General Hospital, Yawkey Center for Outpatient Care | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Memorial Sloan-Kettering | New York | New York | 10021 | United States |
| Carolinas Hematology-Oncology Associates | Charlotte | North Carolina | 28203 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6868 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Országos Korányi TBC és Pulmonológiai Intézet | Budapest | H-1529 | Hungary |
| University of Debrecen | Debrecen | H-4012 | Hungary |
| Akademia Medyczna W Gdansku | Gdansk | 80-952 | Poland |
| Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy | Otwock | 05-400 | Poland |
| Wielkopolskie Centrum Chorób Płuc i Gruźlicy | Poznan | 60-569 | Poland |
| Dolnośląskie Centrum Chorób Płuc we Wrocławiu | Wroclaw | 54-439 | Poland |
| Hospital Germans Trias I Puyol | Badalona | Barcelona | 08916 | Spain |
| FG001 | Prior Tarceva or Iressa w/o EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| FG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prior Tarceva or Iressa With EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| BG001 | Prior Tarceva or Iressa w/o EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| BG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer | Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. | modified ITT: Subjects who were randomized and who had taken at least 1 dose of neratinib; equivalent to the safety population | Posted | Number | 90% Confidence Interval | percentage of participants | From first dose date to progression/death or last tumor assessment, up to three years. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer | Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Posted | Number | 90% Confidence Interval | percentage of participants | From first dose date to progression/death or last tumor assessment, up to three years. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer | Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. | Number of subjects with PR or higher response. | Posted | Median | 90% Confidence Interval | weeks | From start date of response to first PD, assessed up to three years after the first randomization. |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer | Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Median | 90% Confidence Interval | weeks | From first dose date to progression/death, assessed up to three years. |
|
First dose through 28 days after last dose, assessed up to three years.
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 | Prior Tarceva or Iressa With EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. | 33 | 91 | 91 | 91 | ||
| EG001 | Prior Tarceva or Iressa w/o EGFR Mutation | Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. | 21 | 48 | 46 | 48 | ||
| EG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. | 14 | 28 | 26 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral venous thrombosis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Cell death | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Operations | Puma Biotechnology, Inc. | +1 (424) 248-6500 | clinicaltrials@pumabiotechnology.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487932 | neratinib |
Not provided
Not provided
Not provided
| >= 60 years |
|
| Male |
|
| OG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
|
|
| OG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
|
|
| OG002 | No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. |
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