Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001762-85 |
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This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1507 | Drug | iv 9mg/kg weekly |
| |
| erlotinib [Tarceva] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) | The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Overall Survival | The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | From start of treatment to death; up to the time that all participants ended treatment |
| Participants Achieving Objective Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica | California | 90404 | United States | |||
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | R1507 | 9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
150mg oral daily |
|
Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. |
| Patients were followed from start of therapy until date of first response |
| Time to Best Response | This is defined as time from the start of therapy to the date of first CR or PR. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | Patients were followed from start of therapy until date of first response |
| Time to Progressive Disease (PD) | The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment. |
| Duration of Objective Response | This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken |
| Baseline Electrocardiogram (ECG) | Standard safety monitoring includes baseline Electrocardiogram (ECG). The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | baseline within 28 days of starting treatment (screening visit). |
| Fasting Glucose, Highest Post-Baseline Value | A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant's baseline glucose level is reported. | Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks) |
| Hemoglobin A1c (HbA1c) | Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS). | screening |
| Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential | Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS). | Within 7 days of starting treatment (baseline visit) |
| Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing | Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity. To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives. | prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks) |
| Electrocardiogram (ECG) | 12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided). | baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks) |
| Population Pharmacokinetics of R1507 and Tarceva | Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial. | Throughout study |
| Assessment of Potential Predictive and Prognostic Biomarkers. | Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial. | Throughout study |
| Miami |
| Florida |
| 33101 |
| United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02215 | United States |
| Hickory | North Carolina | 28602 | United States |
| Calgary | Alberta | T2N 4N2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Marseille | 13015 | France |
| Paris | 75230 | France |
| Villejuif | 94805 | France |
| Gdansk | 80-211 | Poland |
| Lublin | 20-950 | Poland |
| Poznan | 60-569 | Poland |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | R1507 | 9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | All baseline measures are based on the safety population that includes all participants who received at least one dose of study drug. | 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 Progression Free Survival (PFS) | The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks. | All Treated Population | Posted | Number | Percentage of participants | 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Survival | The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | All Treated Population | Posted | From start of treatment to death; up to the time that all participants ended treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Participants Achieving Objective Response | Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | All Treated Population | Posted | Patients were followed from start of therapy until date of first response |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Best Response | This is defined as time from the start of therapy to the date of first CR or PR. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | All Treated Population | Posted | Patients were followed from start of therapy until date of first response |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease (PD) | The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | All Treated Population | Posted | From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response | This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | All Treated Population | Posted | from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Electrocardiogram (ECG) | Standard safety monitoring includes baseline Electrocardiogram (ECG). The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. | Safety Population | Posted | baseline within 28 days of starting treatment (screening visit). |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Glucose, Highest Post-Baseline Value | A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant's baseline glucose level is reported. | Safety Population: based on the total number of participants n = 34 | Posted | Number | participants | Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin A1c (HbA1c) | Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS). | Safety Population | Posted | screening |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential | Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing. Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS). | Female patients of childbearing potential | Posted | Within 7 days of starting treatment (baseline visit) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing | Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity. To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives. | Safety Population | Posted | Number | participants | prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Electrocardiogram (ECG) | 12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided). | Safety Population | Posted | Mean | Standard Deviation | ms (millisecond) | baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Population Pharmacokinetics of R1507 and Tarceva | Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial. | Population PK of R1507 and erlotinib | Posted | Throughout study |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Potential Predictive and Prognostic Biomarkers. | Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial. | Responders and non-responders | Posted | Throughout study |
|
|
From start of treatment until 30 days after last dose (up to 64 weeks) or if the AE was related to study drug, up until the AE resolved
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 | R1507 | 9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) | 12 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DECREASED APPETITE | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAIL TOXICITY | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| SKIN TOXICITY | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| EPISTAXIS | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MYALGIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NECK PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PARONYCHIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BLOOD MAGNESIUM DECREASED | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSGEUSIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPHONIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FATIGUE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HEADACHE | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PRESYNCOPE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| SKIN REACTION | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| SOMNOLENCE | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | General disorders | MedDRA 13.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung 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 |
|---|---|
| C558734 | RG-1507 monoclonal antibody |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO)
Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL
| OG003 | R1507_Baseline Missing | 9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline |
|
|
|
|