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The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 2536 High dose | Experimental | Day 1 |
|
| BI 2536 Low dose | Experimental | Day 1 - 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 2536 | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Objective Response Evaluated According to the RECIST Criteria by Independent Review | Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown. | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour Control After the Fourth Treatment Course | Tumour control rate was defined as the number of patients in a treatment arm who had completed 4 courses of treatment and presented with Stable Disease (SD), Partial Response (PR), or Complete Remission (CR). Tumour assessment by independent review of tumour imaging according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. The secondary endpoint "duration of overall response" was integrated into and displayed with tumour control endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1216.10.43001 Boehringer Ingelheim Investigational Site | Vienna | Austria | ||||
| 1216.10.49013 Boehringer Ingelheim Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study.
This study was an open, randomised, clinical phase II trial in patients with unresectable advanced pancreatic cancer investigating the efficacy, safety, and pharmacokinetics of BI 2536 administered in repeated 3-week cycles as a single IV dose of 200 mg on Day 1 or as 60 mg doses on Days 1, 2, and 3
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| ID | Title | Description |
|---|---|---|
| FG000 | 200mg BI 2536 IV on Day 1 | 200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tumour measurements performed at screening (day -21 to -1) and at the end of of the fourth 3-week treatment cycle, up to 105 days. |
| Duration of Overall Response | The duration of overall response was measured from the time measurement criteria were met for complete remission (CR) or partial remission (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented, taking as reference for progressive disease the smallest measurements recorded since the treatment started. Tumour assessment by independent review of tumour imaging by an external CRO according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
| Progression Free Survival (PFS) | Progression free survival (PFS) was defined as the duration of time from randomisation to time of progression or death. For patients without documented progression at the time of analysis, PFS was censored as the total observation time without new anti-cancer therapy. PFS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. Progressive disease: At least a 20% increase in the sum of Longest Diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
| Overall Survival (OS) | Overall survival (OS) was the time from first treatment until death. If there was no occurrence of death or progression until the last follow-up of the trial, the time was to be censored at the date of last trial visit. OS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. The secondary endpoint "One-year survival" was integrated into the secondary endpoint overall survival. | From first treatment till the end of the trial or when a patient concluded the trial, up to 336 days. |
| Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment | Best objective response: Tumour assessment by investigator assessment of tumour imaging according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown. | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
| One-year Survival | One-year survival was defined as survival at 1 year after randomisation. For the cohort of first line patients, this time point coincided with the beginning of treatment with the Trial drug. For second line patients, 1 year survival was defined as 1 year after the start of the previous first line treatment for pancreatic cancer. | 1 year, see description for detailed definition of the time frame. |
| Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response | Number of participants with carbohydrate antigen 19-9 (CA19-9) response rate was defined as the proportion of patients with a decrease in CA19-9 serum levels of ≥25% from baseline in 2 consecutive measurements performed ≥4 weeks apart. Additionally, the proportion of patients with an improved response was assessed, i.e. a decrease in CA19-9 of ≥75% at 2 consecutive measurements ≥4 weeks apart. By definition, a positive CA19-9 response could not occur in patients with normal baseline CA19-9 levels. | Blood samples for CA19-9 analysis were collected on Days 1, 2, and 5 of each treatment period, up to 357 days. |
| Number of Participants With Dose Limiting Toxicity (DLT) | Dose limiting toxicity (DLT) was defined as drug-related CTCAE (Common Terminology Criteria for Adverse Events, version 3.0) grade ≥3 non-haematological toxicity (excluding untreated nausea, vomiting or diarrhoea), drug related CTCAE grade 4 neutropenia for ≥7 days and / or complicated by infection of CTCAE grade 4, or drug related CTCAE grade 4 haematological toxicity other than neutropenia. | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
| Quality of Life Assessment, Including Clinical Benefit Response: Overall Health | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days. |
| Quality of Life Assessment, Including Clinical Benefit Response: Quality of Life | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days. |
| Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) | Number of participants with incidence and intensity of Adverse Events (AE) graded according to CTCAE. Intensity of AEs was scaled according to US-NCI CTCAE, version 3.0. Severity grades 1 to 5 were based on the following general guidelines, with unique clinical descriptions of severity for each AE:
| From first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days. |
| Celle |
| Germany |
| 1216.10.49009 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1216.10.49007 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1216.10.49001 Boehringer Ingelheim Investigational Site | Freiburg/Breisgau | Germany |
| 1216.10.49005 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1216.10.49010 Boehringer Ingelheim Investigational Site | Herne | Germany |
| 1216.10.49008 Boehringer Ingelheim Investigational Site | München | Germany |
| 1216.10.49003 Boehringer Ingelheim Investigational Site | Stuttgart | Germany |
| 1216.10.49002 Boehringer Ingelheim Investigational Site | Ulm | Germany |
| FG001 |
| 60mg BI 2536 IV on Day 1-3 |
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200mg BI 2536 IV on Day 1 | 200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
| BG001 | 60mg BI 2536 IV on Day 1-3 | 60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Quality of Life: Overall health | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Quality of Life: Quality of life | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Mean | Standard Deviation | Score on a scale |
|
| 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 | Best Objective Response Evaluated According to the RECIST Criteria by Independent Review | Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline. | Posted | Count of Participants | Participants | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
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| Secondary | Tumour Control After the Fourth Treatment Course | Tumour control rate was defined as the number of patients in a treatment arm who had completed 4 courses of treatment and presented with Stable Disease (SD), Partial Response (PR), or Complete Remission (CR). Tumour assessment by independent review of tumour imaging according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. The secondary endpoint "duration of overall response" was integrated into and displayed with tumour control endpoints. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline. | Posted | Count of Participants | Participants | Tumour measurements performed at screening (day -21 to -1) and at the end of of the fourth 3-week treatment cycle, up to 105 days. |
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| Secondary | Duration of Overall Response | The duration of overall response was measured from the time measurement criteria were met for complete remission (CR) or partial remission (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented, taking as reference for progressive disease the smallest measurements recorded since the treatment started. Tumour assessment by independent review of tumour imaging by an external CRO according to RECIST after every second treatment course, including imaging (e.g. CT, MRI) and submission of image(s) to central imaging unit. | All patients who received at least 1 single dose of BI 2536, who had an evaluation after baseline and who had an unconfirmed best overall response by independent review. | Posted | Median | Standard Deviation | Days | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
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| Secondary | Progression Free Survival (PFS) | Progression free survival (PFS) was defined as the duration of time from randomisation to time of progression or death. For patients without documented progression at the time of analysis, PFS was censored as the total observation time without new anti-cancer therapy. PFS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. Progressive disease: At least a 20% increase in the sum of Longest Diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. | Posted | Median | 95% Confidence Interval | days | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
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| Secondary | Overall Survival (OS) | Overall survival (OS) was the time from first treatment until death. If there was no occurrence of death or progression until the last follow-up of the trial, the time was to be censored at the date of last trial visit. OS was analysed with the Kaplan-Meier method for each of the treatment arms. Kaplan-Meier estimates and confidence intervals were tabulated at specific points in time. Greenwood's variance estimate was used to form confidence intervals. The secondary endpoint "One-year survival" was integrated into the secondary endpoint overall survival. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. | Posted | Median | 95% Confidence Interval | days | From first treatment till the end of the trial or when a patient concluded the trial, up to 336 days. |
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| Secondary | Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment | Best objective response: Tumour assessment by investigator assessment of tumour imaging according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 4 patients did not have any evaluations after baseline. | Posted | Count of Participants | Participants | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
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| Secondary | One-year Survival | One-year survival was defined as survival at 1 year after randomisation. For the cohort of first line patients, this time point coincided with the beginning of treatment with the Trial drug. For second line patients, 1 year survival was defined as 1 year after the start of the previous first line treatment for pancreatic cancer. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. | Posted | Number | participants | 1 year, see description for detailed definition of the time frame. |
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| Secondary | Number of Participants With Carbohydrate Antigen 19-9 (CA19-9) Response | Number of participants with carbohydrate antigen 19-9 (CA19-9) response rate was defined as the proportion of patients with a decrease in CA19-9 serum levels of ≥25% from baseline in 2 consecutive measurements performed ≥4 weeks apart. Additionally, the proportion of patients with an improved response was assessed, i.e. a decrease in CA19-9 of ≥75% at 2 consecutive measurements ≥4 weeks apart. By definition, a positive CA19-9 response could not occur in patients with normal baseline CA19-9 levels. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 19 patients did not have elevated CA19-9 levels at baseline and could not be included. | Posted | Count of Participants | Participants | Blood samples for CA19-9 analysis were collected on Days 1, 2, and 5 of each treatment period, up to 357 days. |
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| Secondary | Number of Participants With Dose Limiting Toxicity (DLT) | Dose limiting toxicity (DLT) was defined as drug-related CTCAE (Common Terminology Criteria for Adverse Events, version 3.0) grade ≥3 non-haematological toxicity (excluding untreated nausea, vomiting or diarrhoea), drug related CTCAE grade 4 neutropenia for ≥7 days and / or complicated by infection of CTCAE grade 4, or drug related CTCAE grade 4 haematological toxicity other than neutropenia. | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 1 participants did not experience any adverse event and was not included in the analysis. | Posted | Count of Participants | Participants | Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days. |
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| Secondary | Quality of Life Assessment, Including Clinical Benefit Response: Overall Health | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline. | Posted | Mean | Standard Deviation | Score on a scale | Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days. |
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| Secondary | Quality of Life Assessment, Including Clinical Benefit Response: Quality of Life | Quality of life (QOL) was measured using the widely used and validated measure the European Organization for Research and Treatment - Quality of Life Questionnaire (EORTC QLQ-C30), based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?", scored between 1 (very poor) to 7 (Excellent). | Treated Set (TS): all patients who received at least 1 single dose of BI 2536 and who had an evaluation after baseline. | Posted | Mean | Standard Deviation | Score on a scale | Data from the last available questionnaire for each patient. Questionnaires were taken at screening (day -21 to -1), at the beginning (Day 1) and end (Day 22 ± 3) of every treatment period (3 weeks), and at the end of the trial, up to 357 days. |
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| Secondary | Number of Participants With Incidence and Intensity of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) | Number of participants with incidence and intensity of Adverse Events (AE) graded according to CTCAE. Intensity of AEs was scaled according to US-NCI CTCAE, version 3.0. Severity grades 1 to 5 were based on the following general guidelines, with unique clinical descriptions of severity for each AE:
| Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason. 1 patient did not experience any AE and was not included in the endpoint. | Posted | Count of Participants | Participants | From first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days. |
|
from first administration until 21 days after the day of last administration, up to 16 cycles, up to 357 days.
Treated Set (TS): all patients who received at least 1 single dose of BI 2536 were considered, including patients who had been replaced for any reason.
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 | 200mg BI 2536 IV on Day 1 | 200 milligram (mg) given as an intravenous (IV) infusion on day 1 of each 3 week cycle, to a total dose of 200 mg. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. | 32 | 43 | 22 | 43 | 41 | 43 |
| EG001 | 60mg BI 2536 IV on Day 1-3 | 60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. | 35 | 43 | 23 | 43 | 41 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bile duct stent insertion | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Drug administration error | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C518477 | BI 2536 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stable disease |
|
| No best response |
|
| Unconfirmed best overall response |
|
Confirmed objective response, comparison with historical controls (Gemcitabine)
| Exact binomial test |
| 0.9156 |
p0 = 0.092, one sided exact binomial test with a 2.5% significance level |
| Maximum likelihood estimation |
| 0.0233 |
| 2-Sided |
| 95 |
| 0.0006 |
| 0.1229 |
| Other |
| Confirmed objective response, comparison with historical controls (Gemcitabine) | Exact binomial test | 0.7021 | p0 = 0.056, one sided exact binomial test with a 2.5% significance level | Maximum likelihood estimation | 0.0233 | 2-Sided | 95 | 0.0006 | 0.1229 | Other |
| Confirmed objective response, comparison with historical controls (Gemcitabine) | Exact binomial test | 0.9156 | p0 = 0.092, one sided exact binomial test with a 2.5% significance level | Maximum likelihood estimation | 0.0233 | 2-Sided | 95 | 0.0006 | 0.1229 | Other |
| OG001 | 60mg BI 2536 IV on Day 1-3 | 60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
|
|
|
|
60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
|
|
|
|
|
|
| OG001 | 60mg BI 2536 IV on Day 1-3 | 60 milligram (mg) given as an intravenous (IV) infusion on day 1, 2 and 3 of each 3 week cycle. Each patient was to receive at least 2 treatment courses. In the case of benefit (i.e. at least stable disease and acceptable tolerability), the patient could continue therapy with the trial drug. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Stable disease |
|
| No best response |
|