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This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MetMAb + Erlotinib | Experimental | MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
|
| Placebo + Erlotinib | Placebo Comparator | Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib HCl | Drug | Erlotinib 150 mg oral dose once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment). | Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) |
| Progression-free Survival in Patients With Met Diagnostic-Positive Tumors | Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment). | Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response | Objective response (partial and complete response as determined using RECIST 1.0). Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions. | Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) |
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Inclusion Criteria:
Patients must meet the following criteria for study entry:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Premal Patel, M.D., Ph.D. | Genentech, Inc. | Study Director |
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Twenty-seven patients in the placebo + erlotinib arm with disease progression in the blinded treatment stage elected to receive MetMAb + erlotinib in the optional open-label phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MetMAb + Erlotinib | MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
| FG001 | Placebo + Erlotinib | Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MetMAb + Erlotinib | MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
| BG001 | Placebo + Erlotinib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression-free Survival | Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment). | All randomized intent-to-treat patients. | Posted | Number | 95% Confidence Interval | months | Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) |
|
Up to 20 months
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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 | MetMAb + Erlotinib | MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| 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 |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| C584058 | onartuzumab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| MetMAb | Drug | MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks. |
|
| placebo (0.9 % saline) | Drug | Placebo Intravenous infusion every 3 weeks. |
|
| Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors | Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry. Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions. | Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) |
| Duration of Overall Response | Date of initial response until date of progression or death on study. (Up to 20 months) |
| Death |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Sponsor's decision to terminate study |
|
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. |
|
|
|
| Secondary | Percentage of Participants With Objective Response | Objective response (partial and complete response as determined using RECIST 1.0). Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions. | All randomized intent-to-treat patients. | Posted | Number | 95% Confidence Interval | Percentage of participants | Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) |
|
|
|
|
| Secondary | Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors | Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry. Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions. | All randomized intent-to-treat patients with Met Diagnostic-positive tumors. | Posted | Number | 95% Confidence Interval | Percentage of participants | Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) |
|
|
|
|
| Primary | Progression-free Survival in Patients With Met Diagnostic-Positive Tumors | Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment). | All randomized intent-to-treat patients with Met Diagnostic-Positive tumors. | Posted | Median | 95% Confidence Interval | months | Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) |
|
|
|
|
| Secondary | Duration of Overall Response | All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses. | Posted | Date of initial response until date of progression or death on study. (Up to 20 months) |
|
|
| 29 |
| 69 |
| 68 |
| 69 |
| EG001 | Placebo + Erlotinib | Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity. | 22 | 67 | 67 | 67 |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
|
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
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| DEATH | General disorders | MedDRA | Systematic Assessment |
|
| HERNIA OBSTRUCTIVE | General disorders | MedDRA | Systematic Assessment |
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| PAIN | General disorders | MedDRA | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| OBSTRUCTIVE AIRWAYS DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PULMONARY ARTERY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA | Systematic Assessment |
|
| EMBOLISM VENOUS | Vascular disorders | MedDRA | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
| SUPERIOR VENA CAVAL OCCLUSION | Vascular disorders | MedDRA | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
|
| PAIN | General disorders | MedDRA | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |