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| ID | Type | Description | Link |
|---|---|---|---|
| STU00038215 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| Robert H. Lurie Cancer Center | OTHER |
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Hsp90 inhibitor AUY922 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of Hsp90 inhibitor AUY922 when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer.
This is a phase I, dose-escalation study of Hsp90 inhibitor AUY922 followed by a phase II study. Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I) Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD. DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol. | During the first 4 weeks of treatment for each patient. |
| Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 | Overall response rate (ORR) will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR), defined as >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions | At 8 weeks from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | To characterize the toxicity profile for the combination of erlotinib and AUY922. Toxicity data will be collected every week for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Johnson | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Memorial Sloan-Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25870087 | Derived | Johnson ML, Yu HA, Hart EM, Weitner BB, Rademaker AW, Patel JD, Kris MG, Riely GJ. Phase I/II Study of HSP90 Inhibitor AUY922 and Erlotinib for EGFR-Mutant Lung Cancer With Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors. J Clin Oncol. 2015 May 20;33(15):1666-73. doi: 10.1200/JCO.2014.59.7328. Epub 2015 Apr 13. |
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The study opened for accrual on March 28, 2011 with an accrual goal of up to 30 patients in phase I and 25 patients in phase II. 18 patients were enrolled treated in phase I and 19 patients treated in phase II. The study was closed permanently on May 6, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Reached First Response at 4 Weeks |
|
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| Hsp90 inhibitor AUY922 | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| needle biopsy | Procedure | Undergo image-guided needle biopsy (correlative studies) |
|
|
| mutation analysis | Genetic | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
| At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half years |
| Incidence of Reported Adverse Events in Phase I | Adverse events will be collected weekly for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half years |
| Progression-free Survival (Phase II) | Median Progression Free Survival (PFS) will be calculated from time of treatment initiation until the first documentation of progressive disease. Patients will be considered to have progressive disease when CT scan or MRI show at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment |
| Overall Survival (Phase II) | Overall survival (OS) is defined as the time from treatment initiation until death due to any cause. | From the time of first treatment with AUY922 to death, followed up to 2 years post treatment |
| Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II) | Overall Survival (OS) will be measured from treatment initiation until death due to any cause for patients with acquired resistance with T790M mutations in the phase II portion of the study. | From the time of first treatment with AUY922 to death, followed for up to 2 years |
| New York |
| New York |
| 10065 |
| United States |
| FG001 | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| FG002 | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| FG003 | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| FG004 | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| FG005 | Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| Started Treatment on Study |
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| Completed 4 Weeks of Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| Confirmed Response at 8 Weeks |
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| Continued Treatment After 8 Weeks |
|
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| Survival Follow up for Two Years |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I) Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD. DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol. | Posted | Number | Number of DLTs seen | During the first 4 weeks of treatment for each patient. |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 | Overall response rate (ORR) will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR), defined as >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions | All patients that were treated at the MTD dose of 70mg/m2 AUG922 IV were evaluable for this outcome measure (This includes patients treated in cohort 5 of phase I and all patients treated in phase II of the study) | Posted | Count of Participants | Participants | At 8 weeks from treatment initiation |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | To characterize the toxicity profile for the combination of erlotinib and AUY922. Toxicity data will be collected every week for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Toxicity collected from all patients treated at the MTD of 70mg/m2 AUY922. 6 patients in phase I and 19 patients in phase II were treated at this dose. | Posted | Number | participants | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Reported Adverse Events in Phase I | Adverse events will be collected weekly for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Most frequent adverse events for patients treated with 25 to 55mg/m2 dose of AUY9222. | Posted | Number | participants | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Phase II) | Median Progression Free Survival (PFS) will be calculated from time of treatment initiation until the first documentation of progressive disease. Patients will be considered to have progressive disease when CT scan or MRI show at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal. | Posted | Median | 95% Confidence Interval | Months | From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (Phase II) | Overall survival (OS) is defined as the time from treatment initiation until death due to any cause. | 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal. | Posted | Median | 95% Confidence Interval | Months | From the time of first treatment with AUY922 to death, followed up to 2 years post treatment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II) | Overall Survival (OS) will be measured from treatment initiation until death due to any cause for patients with acquired resistance with T790M mutations in the phase II portion of the study. | No data was collected or analyzed for this outcome measure. There is no data to report. IND was withdrawn before the studies anticipated termination date. | Posted | From the time of first treatment with AUY922 to death, followed for up to 2 years |
|
|
Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
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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 | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 3 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 3 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 3 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 6 | 6 | 2 | 6 | 6 | 6 |
| EG005 | Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib | Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. erlotinib hydrochloride: Given orally Hsp90 inhibitor AUY922: Given IV laboratory biomarker analysis: Correlative studies needle biopsy: Undergo image-guided needle biopsy (correlative studies) mutation analysis: Correlative studies pharmacological study: Correlative studies | 13 | 19 | 1 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Patient also experienced anemia |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Patient also experienced diarrhea and anemia |
|
| Ileal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Patient also had seizure due to not being able to take keppa because of nausea and vomiting. |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tumor pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | Worsening symptoms included dyspnea and pleural effusion |
|
| Diarrhea with blood | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Titnnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Corneal ulcer | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Night blindness | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Activated Partial Thromboplastin time Prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| INR Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Serum Amylase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle Weakness, Left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erythema Multiforme | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Menopause | Social circumstances | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleeding | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleeding gums | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood in sputum | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Visual Disturbances | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Trichiasis of the eyelid | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fissures | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Clostridium Difficile (C Diff) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased Appetite | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cold intolerance | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Taste changes | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruise at port site | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Night Sweats | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Reaction at port site | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle cramps | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremors | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leg and hip pain/weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash from cut | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sores in mouth | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Redness on bottom lip | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| New progressive leptomeningeal disease | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office | Northwestern University | 312-695-1301 |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| C528044 | 5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide |
| D001707 | Biopsy, Needle |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Adverse Event |
|
| Progressive disease |
|
| Adverse Event |
|
| Progressive disease |
|
| Lost to Follow-up |
|
| stopped being followed as study closed |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
|