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| ID | Type | Description | Link |
|---|---|---|---|
| ML20773 |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-deoxy-2-[18F]fluoro-D-glucose (FDG) | Other | FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%. | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
| PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
| Progression Free Survival of Groups by FLT Response at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With FDG-PET Responses | In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Fine, M.D. | Genentech, Inc. | Study Director |
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A single-arm, open-label, multicenter, international pilot study. The study was expected to enroll approximately 100 evaluable patients at approximately eight sites in Australia and the United States. The study was initiated on 6 DEC 2006 and completed on 23 APR 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans. FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 3'-deoxy-3'-[18F]fluorothymidine (FLT) | Other | FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection. |
|
| erlotinib HCl | Drug | Tablets taken orally 150 mg/day. |
|
|
| Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
| Overall Survival of Groups by FDG Response at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%. | From first erlotinib treatment to death, assessed up to 2 years |
| Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | From first erlotinib treatment to death, assessed up to 2 years |
| Overall Survival of Groups by FLT Response at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. | From first erlotinib treatment to death, assessed up to 2 years |
| Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | From first erlotinib treatment to death, assessed up to 2 years |
| Day 14 and Day 56 |
| Percentage of Patients With FLT-PET Responses | In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. | Day 14 and Day 56 |
| FDG Response in Subgroups by CT Response at Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. | Day 56 |
| FLT Response in Subgroups by CT Response at Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. | Day 56 |
| Number of Participants With Adverse Events Due to FLT-PET Imaging | The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET. | From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded. |
| Treated With Erlotinib |
|
| FDG-PET Evaluable |
|
| FLT-PET Evaluable |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients who were treated with any dose of erlotinib were included in the summary of baseline measures. | 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 | Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%. | FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment. | Posted | Median | Full Range | weeks | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
|
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| Secondary | Percentage of Patients With FDG-PET Responses | In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. | FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 and Day 56 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start. | Posted | Median | Full Range | weeks | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With FLT-PET Responses | In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. | FLT-Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 and Day 56 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival of Groups by FLT Response at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. | FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment. | Posted | Median | Full Range | weeks | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
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| Primary | Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start. | Posted | Median | Full Range | weeks | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years |
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| Primary | Overall Survival of Groups by FDG Response at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%. | FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive. | Posted | Median | Full Range | months | From first erlotinib treatment to death, assessed up to 2 years |
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| Secondary | FDG Response in Subgroups by CT Response at Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. | FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 56 |
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| Secondary | FLT Response in Subgroups by CT Response at Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. | FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 56 |
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| Primary | Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start. | Posted | Median | Full Range | months | From first erlotinib treatment to death, assessed up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival of Groups by FLT Response at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. | FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive. | Posted | Median | Full Range | months | From first erlotinib treatment to death, assessed up to 2 years |
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| Primary | Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. | Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive. CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. | Posted | Median | Full Range | months | From first erlotinib treatment to death, assessed up to 2 years |
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| Secondary | Number of Participants With Adverse Events Due to FLT-PET Imaging | The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET. | Patients with non-small cell lung cancer (NSCLC) who underwent FLT-PET scans. | Posted | Number | Participants | From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded. |
|
|
Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year)
Includes evaluation of all Safety-Evaluable Patients [n = 85].
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 | Erlotinib | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi. | 37 | 85 | 46 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| TRACHEO-OESOPHAGEAL FISTULA | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal 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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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
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| TRACHEO-OESOPHAGEAL FISTULA | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA | Systematic Assessment |
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| DISEASE PROGRESSION | 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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| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| DERMATITIS INFECTED | Infections and infestations | MedDRA | Systematic Assessment |
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| GANGRENE | Infections and infestations | MedDRA | Systematic Assessment |
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| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| LOBAR PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| PARONYCHIA | Infections and infestations | MedDRA | Systematic Assessment |
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| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| OVERDOSE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| BLOOD GLUCOSE INCREASED | Investigations | MedDRA | Systematic Assessment |
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| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA | Systematic Assessment |
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| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
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| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA | Systematic Assessment |
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| NEURALGIA | Nervous system disorders | MedDRA | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
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| SCIATICA | Nervous system disorders | MedDRA | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
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| DISORIENTATION | Psychiatric disorders | MedDRA | Systematic Assessment |
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| URINARY RETENTION | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| 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.
| 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 |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| C002854 | alovudine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
| OG001 | Erlotinib_FDG Progressive Disease With CT SD at Day 56 | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group. |
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| OG001 | Erlotinib_FLT Progressive Disease With CT SD at Day 56 | Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group. |
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| OG001 |
| Erlotinib_FDG Progressive Disease With CT SD at Day 56 |
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group. |
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| Erlotinib_FLT Progressive Disease With CT SD at Day 56 |
Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group. |
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