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Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 2536 | Experimental | Total Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 2536 | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Tumor Response | Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). | Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as 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. |
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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 |
|---|---|---|---|---|---|---|
| 1216.11.007 Boehringer Ingelheim Investigational Site | Fayetteville | Arkansas | United States | |||
| 1216.11.003 Boehringer Ingelheim Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This is an open-label Phase II trial to investigate the efficacy, safety, and pharmacokinetics of a single dose of 200 mg i.v. BI 2536 administered every 21 days in patients with sensitive relapse small cell lung cancer using an uncontrolled, Gehan two-stage trial design with an early stopping rule based on patient response.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 2536 200 mg | Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 2536 200 mg | Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Objective Tumor Response | Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). | Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. Four patients were excluded from this endpoint due to not having completed two treatment cycles (21 days each). | Posted | Count of Participants | Participants | Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
|
Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks.
Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.
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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 | BI 2536 200 mg | Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
The criteria for expanding the trial to the second stage were not achieved and the trial was stopped early per trial design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D018288 | Carcinoma, Small Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C518477 | BI 2536 |
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| Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
| Overall Survival | Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial. | From the start of treatment till death or discontinuation, up to 36 weeks. |
| Duration of Overall Response | The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (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) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). | Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
| Occurrence and Intensity of Adverse Events Graded According to CTCAE | Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0. | From the start of treatment till the last infusion + 21 days, up to 36 weeks. |
| Number of Participants With Dose Limiting Toxicity | Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as:
| From the start of treatment till the last treatment + 21 days, up to 36 weeks. |
| Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures | Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade). | From the start of treatment till the last treatment + 21 days, up to 36 weeks. |
| Chicago |
| Illinois |
| United States |
| 1216.11.006 Boehringer Ingelheim Investigational Site | Evanston | Illinois | United States |
| 1216.11.002 Boehringer Ingelheim Investigational Site | Boston | Massachusetts | United States |
| 1216.11.005 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1216.11.001 Boehringer Ingelheim Investigational Site | Chapel Hill | North Carolina | United States |
| 1216.11.011 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1216.11.010 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1216.11.012 Boehringer Ingelheim Investigational Site | Seattle | Washington | United States |
| 1216.11.009 Alberta Cancer Board | Edmonton | Alberta | Canada |
| Progressive disease |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| BI 2536 200 mg |
Patients received a single intravenous infusion of 200 milligram (mg) BI 2536 on day 1 of each 21 day treatment cycle. Beyond the second treatment cycle patients may either be treated with the original dose or may receive a higher dose in case of clinical benefit and good tolerability. BI 2536 dosing can be increased in steps of 50 mg. Dose escalations may be repeated after every other course. |
|
|
| Secondary | Progression Free Survival (PFS) | Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as 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. | Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. | Posted | Median | 95% Confidence Interval | days | Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
|
|
|
| Secondary | Overall Survival | Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial. | Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536.. | Posted | Count of Participants | Participants | From the start of treatment till death or discontinuation, up to 36 weeks. |
|
|
|
| Secondary | Duration of Overall Response | The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (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) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). | Analysis of duration of overall response was not conducted, as there were no responders | Posted | Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks. |
|
|
| Secondary | Occurrence and Intensity of Adverse Events Graded According to CTCAE | Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0. | Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. | Posted | Count of Participants | Participants | From the start of treatment till the last infusion + 21 days, up to 36 weeks. |
|
|
|
| Secondary | Number of Participants With Dose Limiting Toxicity | Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as:
| Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. | Posted | Count of Participants | Participants | From the start of treatment till the last treatment + 21 days, up to 36 weeks. |
|
|
|
| Secondary | Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures | Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade). | Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. | Posted | Count of Participants | Participants | From the start of treatment till the last treatment + 21 days, up to 36 weeks. |
|
|
|
| 5 |
| 23 |
| 5 |
| 23 |
| 21 |
| 23 |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | 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 | Measurements |
|---|---|
|
| CTCAE grade 4 |
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| CTCAE grade 5 |
|
| CTC Grade 4 |
|
| no increase in CTC grade |
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| Neutrophil |
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| Aspartate aminotransferase |
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| Alanine aminotransferase |
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| Haemoglobin |
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| Platelets |
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| White blood cell count |
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| Creatinine |
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| Bilirubin, total |
|